Hamm v. Dunn et al

Filing 58

MEMORANDUM OPINION AND ORDER. Signed by Chief Judge Karon O Bowdre on 2/20/2018. (Attachments: # 1 Sealed Appendix)(FNC)

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FILED 2018 Feb-20 AM 08:44 U.S. DISTRICT COURT N.D. OF ALABAMA IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ALABAMA SOUTHERN DIVISION DOYLE LEE HAMM, ] ] Plaintiff, ] ] v. ] ] JEFFERSON S DUNN, COMMISSIONER, ] ALABAMA DEPARTMENT OF ] CORRECTIONS; ] CYNTHIA STEWART, WARDEN, ] HOLMAN CORRECTIONAL FACILITY; ] LEON BOLLING, III, WARDEN, ] DONALDSON CORRECTIONAL FACILITY; ] OTHER UNKNOWN EMPLOYEES AND ] AGENTS, ALABAMA DEPARTMENT OF ] CORRECTIONS ] ] Defendants. ] 2:17-cv-02083-KOB MEMORANDUM OPINION AND ORDER As Chief Justice Roberts and Justice Alito have written, “because it is settled that capital punishment is constitutional, ‘[i]t necessarily follows that there must be a [constitutional] means of carrying it out.’” Glossip v. Gross, 135 S. Ct. 2726, 2732–33 (2015) (Alito, J.) (quoting Baze v. Rees, 553 U.S. 35, 47 (2008) (Roberts, C.J.) (plurality opinion)). Guided by that principle, the court has taken steps to ensure, as far as possible, that the execution of Doyle Lee Hamm meets constitutional standards. Now, the court must rule on Plaintiff Doyle Hamm’s request for a preliminary injunction enjoining Defendants from executing him using intravenous lethal injection. Mr. Hamm bears the burden of showing a substantial likelihood of success on the merits of his claim that Alabama’s method of execution, as applied to him, “presents a risk that is sure or very likely to cause serious illness and needless suffering, and give rise to sufficiently imminent dangers.” Glossip, 135 S. Ct. at 2737 (quotation marks omitted). If Mr. Hamm can make that showing, then he must identify “an alternative that is feasible, readily implemented, and in fact significantly reduces a substantial risk of severe pain.” Id. (quotation marks and alterations omitted). Mr. Hamm contends that his current medical condition, caused by years of intravenous drug use, hepatitis C, and untreated lymphoma, renders his veins severely compromised, and that any attempt to insert an intravenous catheter into his peripheral veins could result in numerous painful sticks and/or infiltration of the lethal drugs into the surrounding tissue, causing a painful and gruesome death. And he asserts that he suffers from untreated lymphadenopathy, which would hinder Alabama’s alternative method of placing a central line into one of the major veins located in his groin, chest, or neck. He seeks, instead, to have the State execute him by “oral injection” using the drugs and a variation on the procedure set out in Oregon’s Death with Dignity Act. See Or. Rev. Stat. §§ 127.800–127.897. On February 6, 2018, this court denied Defendants’ motion for summary judgment on Mr. Hamm’s amended complaint and stayed his execution “for the purpose of obtaining an independent medical examination and opinion concerning the current state of Mr. Hamm’s lymphoma, the number and quality of peripheral venous access, and whether any lymphadenopathy would affect efforts at obtaining central line access.” (Doc. 31 at 2). Defendants appealed this court’s order and on February 13, 2018, the Eleventh Circuit vacated the stay, holding that this court had not made “sufficient factual findings to establish a significant possibility of success on the merits.” (Doc. 38 at 8). The Court directed this court “to immediately appoint an independent medical examiner and schedule an independent medical examination, and to thereafter make any concomitant factual findings—pursuant to a hearing or 2 otherwise—by no later than Tuesday, February 20, 2018, at 5:00 p.m. Central Standard Time.” (Id. at 11–12). On February 15, 2018, the court appointed a physician as its independent medical examiner and ordered him to conduct a medical examination of Mr. Hamm, specifically the condition of his peripheral and central veins. 1 (Doc. 48). The court ordered the physician to report to the court the results of that examination and to advise the court on the standard of care used to place a central line. (Id.). The physician conducted the examination on the same day, and attorneys from both sides observed the examination. The physician’s examination included viewing Mr. Hamm’s veins, palpating them, and using an ultrasound to view the internal veins, organs, and lymph nodes. See Appendix A (Medical Report). As the court had requested, the physician made an oral report to the court in the evening of February 15, shortly after finishing the examination. The medical expert reported that Mr. Hamm has numerous accessible and usable veins in both his upper and lower extremities. But he stated that the peripheral veins in Mr. Hamm’s upper extremities, while accessible, are smaller and more difficult to access. The veins in Mr. Hamm’s lower extremities—particularly from his knees down—are palpable, visible, and easily accessible, and further, the accessible veins in Mr. Hamm’s lower extremities are of sufficient size to accept a catheter and substantial flow of liquid. Although he observed nodes in Mr. Hamm’s groin area, he found that they would not impede access to the femoral vein. He commented that Mr. Hamm has “zero lymphadenopathy.” He concluded that all of Mr. Hamm’s central and deep veins are clear. In short, the physician found no likely problems obtaining 1 For the reasons that the court explained on the record at the February 16, 2018 conference with the parties, the court sealed all information regarding the identity of the physician appointed as the court’s independent medical expert. Because his identity must remain confidential, the court will not refer to him by name. 3 venous access on Mr. Hamm, particularly using the veins in his lower extremities. Because of the results of the examination, the court did not inquire as to the standard of care for starting a central line IV. The next day, February 16, the court held a conference with the parties and counsel, which had originally been scheduled to have testimony concerning the Alabama Department of Corrections’ lethal injection procedures. The court began the conference by relaying the oral report from the court’s medical expert. The court advised the parties that the medical expert’s report resolved the concerns regarding the status of Mr. Hamm’s veins and lymphadenopathy. The court asked if Defendants would stipulate they would not attempt peripheral venous access in Mr. Hamm’s upper extremities; they agreed to so stipulate. The court then found that the medical evidence negated any need to delve further into Alabama’s lethal injection protocol. Nothing about Mr. Hamm’s condition, especially because of Defendants’ stipulation, “presents a risk that [Alabama’s current lethal injection protocol as applied to him] is sure or very likely to cause serious illness and needless suffering, and give rise to sufficiently imminent dangers.” Glossip, 135 S. Ct. at 2737 (quotation marks omitted). And given the medical expert’s report that Mr. Hamm is not experiencing lymphadenopathy, the court determined that further inquiry into the procedure for obtaining central venous access would convert his as-applied challenge into a facial challenge to the lethal injection protocol. As the court found in its memorandum opinion on Defendants’ motion for summary judgment, a facial challenge to Alabama’s lethal injection protocol would be timebarred because such a claim accrued in 2002 and the statute of limitations on it expired in 2004. (See Doc. 30 at 13). 4 Mr. Hamm’s counsel stated numerous objections on the record, which the court overruled. The court promised counsel that it would forward the medical expert’s report to them as soon as it received it. On February 19, 2018, the physician sent his written report to the court, and the court forwarded it to the parties. 2 The written report elaborates on the physician’s oral report to the court with more technical analysis of Mr. Hamm’s veins. The written report determines that Mr. Hamm has accessible and usable veins in his upper and lower extremities. But it further determines that the veins in Mr. Hamm’s upper extremities would be accessible only by an advanced practitioner, such as a CRNA, PA, or MD, using an ultrasound. See Appendix A at 14. The written report concludes: Mr. Hamm has accessible peripheral veins in the following regions. 1. Right great saphenous vein below the level of the knee. The vein is palpable from the medial aspect of the right knee to the anterior portion of the medial malleolus. 2. Left great saphenous vein below the level of the knee. The vein is palpable from the medial aspect of the left knee to the anterior portion of the medial malleolus. 3. Right and left internal jugular veins as well as the right and left subclavian veins and the right and left femoral veins. Access of these veins would require ultrasound guidance to perform and an advanced level practitioner would be required. (CRNA, PA or M.D.) 4. There are no veins in either the left or right upper extremities which would be readily accessible for venous access without difficulty. 5. Given the accessibility of the peripheral veins listed above, it is my medical opinion that cannulation of the central veins will not be necessary to obtain venous access. Id. The court accepts the medical expert’s written report. 2 To maintain the privacy of the physician, a redacted report is filed as Attachment A with this memorandum opinion and order. The court will file the original report under seal. 5 With the record now more fully developed concerning Mr. Hamm’s medical condition, the court again considers whether he established the prerequisites for a preliminary injunction. “The same four-part test applies when a party seeks a preliminary injunction [as when a party seeks a stay of execution].” Grayson v. Warden, 869 F.3d 1204, 1239 n.90 (11th Cir. 2017). The movant must show that “(1) he has a substantial likelihood of success on the merits; (2) he will suffer irreparable injury unless the injunction issues; (3) the stay would not substantially harm the other litigant; and (4) if issued, the injunction would not be adverse to the public interest.” 3 Valle v. Singer, 655 F.3d 1223, 1225 (11th Cir. 2011). As more fully stated on the record at the February 16 conference, the court finds that Mr. Hamm has failed to show a substantial likelihood of success on the merits or that he will suffer irreparable injury unless the injunction issues. Mr. Hamm based his as-applied complaint on the allegations that he lacks adequate peripheral veins to allow peripheral venous access, and that his lymphadenopathy would hinder central venous access. But, as the court stated on the record at the February 16 conference, based on the independent medical examiner’s report about Mr. Hamm’s venous access and lack of lymphadenopathy, and based on Defendants’ stipulation that they will not attempt peripheral venous access in Mr. Hamm’s upper extremities, the court finds that Mr. Hamm has adequate peripheral and central venous access for intravenous lethal injection of a large amount of fluid. He cannot show any medical factors that would make the Alabama lethal injection protocol, as applied to him, more likely to violate the Eighth Amendment than it would for any other inmate who would be executed following that protocol. 3 The Supreme Court has added that a court deciding whether to enjoin an execution must apply “a strong equitable presumption against the grant of a stay where a claim could have been brought at such a time as to allow consideration of the merits without requiring entry of a stay.” Hill v. McDonough, 547 U.S. 573, 584 (2006) (quotation marks omitted). This court already found that Mr. Hamm brought his request for an injunction in a timely manner, and the Eleventh Circuit agreed. (See Doc. 30 at 13–18, 24; Doc. 38 at 4–7). The court will not address that factor again. 6 As a result, Mr. Hamm cannot show a substantial likelihood of success on the merits of his as-applied claim. For the same reasons, he cannot show that he will suffer irreparable injury without a preliminary injunction. Therefore the court DENIES Mr. Hamm’s request for a preliminary injunction. DONE and ORDERED this 20th day of February, 2018. ____________________________________ KARON OWEN BOWDRE CHIEF UNITED STATES DISTRICT JUDGE 7 APPENDIX A Examination Date February 16, 2018 Patient Mr. Doyle Hamm I examined Mr. Doyle Hamm strictly with regards to his venous system, both deep and superficial in both upper and lower extremities.. Mr Hamm was visually examined along with palpation of his veins. A ultrasound was performed to document the size and patency of his veins. Mr. Hamm’s medical records, that were provided, were reviewed.. He has a significant history of hepatitis C and lymphoma of the left orbit. He was previously examined on 1/3/18 by a CRNP with regards to venous access. He was found at that time, to have large straight saphenous veins in both lower extremities and both of his feet. He was documented as having visible veins in the right wrist as well.. No cervical, supraclavicular or axillary lymphadenopathy was palpated. The examination of his veins on 2/16/18 was performed in both a sitting as well as standing position. There were two parts to his examination. First, visual inspection along with palpation of both the left and right upper and lower extremities as well as the neck and feet. Second, a venous ultrasound examination of both the left and right upper and lower extremities, axillary, subclavian and jugular veins was performed. Examination of the upper extremities: Visual and Palpation. As can be seen from the Photos A and B, there are no prominent superficial veins on visual examination on the upper extremities including the left and right arm, forearm and hands. There are no prominent superficial veins visible that would support an IV of sufficient size to administer intravenous fluids. The examination included the palmar and volar aspects of the hand, wrist, forearm, the antecubital fossa and arms. 8 Photo A Photo B Ultrasound examination of the upper extremities. Technique: Using a 6.0 -7.5 MHz probe, a realtime gray scale sonography was performed with and without transducer compression along the course of the basilic vein, the axillary vein, the subclavian vein and the internal jugular vein. Color doppler was also applied with and without distal compression maneuvers. Select spot images were saved. Ultrasound examination of the left and right antecubital fossa did reveal the basilic vein and it was readily visualized with ultrasound. These veins were of adequate size but would be very difficult to access without the use of ultrasound. See photos C and D. Photo C Left Basilic Vein Photo D Right Basilic Vein The more proximal veins including the left and right axillary veins, the left and right subclavian veins and the left and right internal jugular veins were easily identified and compressible representing 9 excellent flow and no proximal obstruction. There was no lymphadenopathy present in either left or right axilla, supraclavicular or cervical regions present on ultrasound. See photos E,F,G,H,I and J. Photo E Left Axillary Vein Photo F Left Subclavian Vein Photo G Left Internal Jugular Vein Photo H Right Axillary Vein Photo I Right Subclavian Vein Photo J Examination of the lower extremities. 10 Right Internal Jugular Vein Visual and Palpation. It should be noted that both Mr. Hamm’s lower extremities, left and right side, were hyperpigmented consistent with venous stasis. No edema in the lower extremities was seen. No secondary varicose veins were identified. The right leg has both an easily seen and palpable great saphenous vein which extends from just below the medial aspect of the right knee to anterior to the medial malleolus. The left leg has a great saphenous vein which is seen ( not as easily as the right leg) and is palpable from just below the medial aspect of the left knee to anterior to the medial malleolus. See photos K and L. Photo K Photo L Ultrasound examination. Technique: Using a 6.0-7.5 MHz probe, a real-time gray scale sonography was performed with and without transducer compression along the course of the femoral vein, the popliteal vein, the great saphenous vein and small saphenous vein. The examination was performed with the patient in the standing position.. Doppler was also applied with and without distal compression maneuvers. Select spot images were saved. Findings. Right side. The right great saphenous vein has venous valvular insufficiency.The right great saphenous vein measures 6.0 millimeters at the saphenofemoral junction, 5.8 millimeters at the mid thigh level, 4.7 millimeters at the knee level and 5.4 millimeters at the mid calf level.There were two lymph nodes identified at the level of the right groin but do not impede venous flow. The right small saphenous 11 vein is competent. The right small saphenous vein measures 2.0 millimeters at the saphenopopliteal junction and 2.2 millimeters at the mid calf region. There is no evidence of deep venous thrombosis, reflux or obstruction in the deep venous system. There is no edema present. See photos N, O, P, Q, R and S. Photo N GSV Right Mid Calf Photo O GSV Right Knee Photo P GSV Right Mid Thigh Photo Q GSV Proximal 12 Photo R Right Inguinal Lymph Nodes Photo S Right Small Saphenous Vein Findings. Left side. The left great saphenous vein has venous valvular insufficiency. The left great saphenous vein measures 5.6 millimeter at the saphenofemoral junction, 3.4 millimeters at the mid thigh, 2.5 millimeters at the knee and 2.5 millimeters at the mid calf region. The left small saphenous vein is competent.. The left small saphenous vein measures 4.2 millimeters at the saphenopopliteal junction and 3.4 millimeters at the mid calf region. There are no lymph nodes present in the left inguinal region. There is no evidence of deep venous thrombosis, reflux or obstruction in t the deep venous system. See photos T, U, V, and X.. Photo T Left Distal GSV Photo U 13 Left GSV Mid Thigh Photo V Left Proximal GSV Photo W Left Small Saphenous Vein In summary, Mr. Hamm has accessible peripheral veins in the following regions. 1. Right great saphenous vein below the level of the knee. The vein is palpable from the medial aspect of the right knee to the anterior portion of the medial malleolus. 2. Left great saphenous vein below the level of the knee. The vein is palpable from the medial aspect of the left knee to the anterior portion of the medial malleolus. 3. Right and left internal jugular veins as well as the right and left subclavian veins and the right and left femoral veins. Access of these veins would require ultrasound guidance to perform and an advanced level practitioner would be required. (CRNA, PA or M.D.) 4. There are no veins in either the left or right upper extremities which would be readily accessible for venous access without difficulty. 5. Given the accessibility of the peripheral veins listed above, it is my medical opinion that cannulation of the central veins will not be necessary to obtain venous access. Carlton Duane Randleman Jr., M.D. 14 Practice Guidelines for Central Venous Access A Report by the American Society of Anesthesiologists Task Force on Central Venous Access P RACTICE Guidelines are systematically developed rec• What other guideline statements are available on this topic? ommendations that assist the practitioner and patient X Several major organizations have produced practice guidein making decisions about health care. These recommenda- tions lines on central venous access128 –132 may be adopted, modified, or rejected according to clinical • Why was this Guideline developed? needs and constraints, and are not intended to re- place local X The ASA has created this new Practice Guideline to provide institutional policies. In addition, Practice Guide- lines developed updated recommendations on some issues and new recby the American Society of Anesthesiologists (ASA) are not ommendations on issues that have not been previously addressed by other guidelines. This was based on a rigorous intended as standards or absolute require- ments, and their use evaluation of recent scientific literature as well as findings from cannot guarantee any specific outcome. Practice Guidelines are surveys of expert consultants and randomly selected ASA subject to revision as warranted by the evolution of medical members knowledge, technology, and prac- tice. They provide basic • How does this statement differ from existing guidelines? recommendations that are sup- ported by a synthesis and X The ASA Guidelines differ in areas such as insertion site selection (e.g., upper body site) guidance for catheter place- ment analysis of the current literature, expert and practitioner (e.g., use of real-time ultrasound) and verification of venous opinion, open forum commentary, and clinical feasibility data. location of the catheter Methodology • Why does this statement differ from existing guidelines? X The ASA Guidelines differ from existing guidelines because it addresses the use of bundled techniques, use of an as- sistant during catheter placement, and management of ar- terial injury A. Definition of Central Venous Access For these Guidelines, central venous access is defined as placement of a catheter such that the catheter is inserted into a venous great vessel. The venous great vessels include the internal jugular veins, subclavian veins, iliac veins, and comsuperior vena cava, inferior vena cava, brachiocephalic veins, mon femoral veins.* Excluded are catheters that terminate in a systemic artery. Developed by the American Society of Anesthesiologists Task Force on Central Venous Access: Stephen M. Rupp, M.D., Seattle, Washington B. Purposes of the Guidelines (Chair); Jeffrey L. Apfelbaum, M.D., Chicago, Illinois; Casey Blitt, M.D., The purposes of these Guidelines are to (1) provide guidTucson, Arizona; Robert A. Caplan, M.D., Seattle, Washington; Richard T. Connis, Ph.D., Woodinville, Washington; Karen B. Domino, M.D., M.P.H., ance regarding placement and management of central veSeattle, Washington; Lee A. Fleisher, M.D., Philadelphia, Pennsylvania; Stuart nous catheters, (2) reduce infectious, mechanical, thromGrant, M.D., Durham, North Carolina; Jonathan B. Mark, M.D., Durham, botic, and other adverse outcomes associated with central North Carolina; Jeffrey P. Morray, M.D., Paradise Valley, Arizona; David G. Nickinovich, Ph.D., Bellevue, Washington; and Avery Tung, M.D., Wilmette, venous catheterization, and (3) improve management of Illinois. arterial trauma or injury arising from central venous cathReceived from the American Society of Anesthesiologists, Park Ridge, eterization. Illinois. Submitted for publication October 20, 2011. Accepted for publication October 20, 2011. Supported by the American Society of Anesthesiologists and C. Focus developed under the direction of the Committee on Standards and Practice Parameters, Jeffrey L. Apfelbaum, M.D. (Chair). Approved by the ASA These Guidelines apply to patients undergoing elective cen- tral House of Delegates on October 19, 2011. Endorsed by the Society of venous access procedures performed by anesthesiologists or Cardiovascular Anesthesiologists, October 4, 2010; the Society of Critical Care Anesthesiologists March 16, 2011; the Society of Pediatric Anesthesia March health care professionals under the direction/supervision of 29, 2011. A complete list of references used to develop these updated anesthesiologists. The Guidelines do not address (1) clin- ical Guidelines, arranged alphabetically by author, is available as Supplemental indications for placement of central venous catheters, (2) Digital Content 1, http://links.lww.com/ALN/A783. emergency placement of central venous catheters, (3) paAddress correspondence to the American Society of Anesthesi- ologists: 520 North Northwest Highway, Park Ridge, Illinois 60068- 2573. These tients with peripherally inserted central catheters, (4) placePractice Guidelines, as well as all ASA Practice Param- eters, may be ment and residence of a pulmonary artery catheter, (5) inserobtained at no cost through the Journal Web site, tion of tunneled central lines (e.g., permacaths, portacaths, www.anesthesiology.org. * This description of the venous great vessels is consistent with the venous subset for central lines defined by the National Health- care @ Supplemental digital content is available for this article. Direct Safety Network (NHSN). URL citations appear in the printed text and are available in both the HTML and PDF versions of this article. Links to the Copyright © 2012, the American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins. Anesthesiology 2012; 116:539 –73 digital files are provided in the HTML text of this article on the Journal’s Web site (www.anesthesiology.org). 15 Practice Guidelines Hickman®, Quinton®, (6) methods of detection or treat- ment Scientific Evidence of infectious complications associated with central ve- nous Study findings from published scientific literature were agcatheterization, or (7) diagnosis and management of central gregated and are reported in summary form by evidence catvenous catheter-associated trauma or injury (e.g., egory, as described in the following paragraphs. All literature pneumothorax or air embolism), with the exception of ca- rotid (e.g., randomized controlled trials, observational studies, case arterial injury. reports) relevant to each topic was considered when evaluat- ing the findings. However, for reporting purposes in this document, only the highest level of evidence (i.e., level 1, 2, or D. Application These Guidelines are intended for use by anesthesiologists and 3 within category A, B, or C, as identified in the following individuals who are under the supervision of an anes- paragraphs) is included in the summary. thesiologist. They also may serve as a resource for other physicians (e.g., surgeons, radiologists), nurses, or health care Category A: Supportive Literature providers who manage patients with central venous Randomized controlled trials report statistically significant (P < 0.01) differences between clinical interventions for a catheters. specified clinical outcome. Level 1: The literature contains multiple randomized conE. Task Force Members and Consultants The ASA appointed a Task Force of 12 members, including trolled trials, and aggregated findings are supported by metaanesthesiologists in both private and academic practice from analysis.‡ various geographic areas of the United States and two con- Level 2: The literature contains multiple randomized consulting methodologists from the ASA Committee on Stan- dards trolled trials, but the number of studies is insuffi- cient to conduct a viable meta-analysis for the pur- pose of these and Practice Parameters. The Task Force developed the Guidelines by means of a seven- Guidelines. step process. First, they reached consensus on the cri- teria for Level 3: The literature contains a single randomized conevidence. Second, original published research stud- ies from trolled trial. peer-reviewed journals relevant to central venous access were reviewed and evaluated. Third, expert consul- tants were asked Category B: Suggestive Literature to (1) participate in opinion surveys on the effectiveness of Information from observational studies permits inference of various central venous access recommenda- tions and (2) review beneficial or harmful relationships among clinical intervenand comment on a draft of the Guide- lines. Fourth, opinions tions and clinical outcomes. about the Guideline recommenda- tions were solicited from a Level 1: The literature contains observational comparisons sample of active members of the ASA. Opinions on selected (e.g., cohort, case-control research designs) of clin- ical topics related to pediatric pa- tients were solicited from a interventions or conditions and indicates statis- tically sample of active members of the Society for Pediatric Anesthesia significant differences between clinical inter- ventions for a (SPA). Fifth, the Task Force held open forums at three major specified clinical outcome. national meetings† to solicit input on its draft recommendations. Level 2: The literature contains noncomparative observaSixth, the consultants were surveyed to assess their opinions on tional studies with associative (e.g., relative risk, correlation) the feasibility of implementing the Guidelines. Seventh, all or descriptive statistics. available informa- tion was used to build consensus within the Level 3: The literature contains case reports. Task Force to finalize the Guidelines. A summary of recommendations may be found in appendix 1. Category C: Equivocal Literature The literature cannot determine whether there are beneficial or harmful relationships among clinical interventions and F. Availability and Strength of Evidence Preparation of these Guidelines followed a rigorous meth- clinical outcomes. odologic process. Evidence was obtained from two principal Level 1: Meta-analysis did not find significant differences (P sources: scientific evidence and opinion-based evidence. > 0.01) among groups or conditions. Level 2: The number of studies is insufficient to conduct † Society for Pediatric Anesthesia Winter Meeting, April 17, 2010, San meta-analysis, and (1) randomized controlled trials have not Antonio, Texas; Society of Cardiovascular Anesthesia 32nd Annual Meeting, April 25, 2010, New Orleans, Louisiana, and Inter- national found significant differences among groups or conditions or Anesthesia Research Society Annual Meeting, May 22, 2011, Vancouver, (2) randomized controlled trials report inconsistent findings. British Columbia, Canada. Level 3: Observational studies report inconsistent findings or ‡ All meta-analyses are conducted by the ASA methodology group. do not permit inference of beneficial or harmful relationships. Meta-analyses from other sources are reviewed but not included as evidence in this document. 16 Disagree. Median score of 2 (at least 50% of responses are 2 Category D: Insufficient Evidence from Literature or 1 and 2). The lack of scientific evidence in the literature is described by the following terms: Strongly Disagree. Median score of 1 (at least 50% of responses are 1). Inadequate: The available literature cannot be used to assess relationships among clinical interventions and clinical outcomes. The literature either does not meet the criteria for content as defined in Category C: Informal Opinion the “Fo- cus” of the Guidelines or does not permit a clear Open-forum testimony, Internet-based comments, letters, interpretation of findings due to methodologic con- cerns (e.g., and editorials are all informally evaluated and discussed dur- ing the development of Guideline recommendations. When confounding in study design or imple- mentation). Silent: No identified studies address the specified relation- ships warranted, the Task Force may add educational information or cautionary notes based on this information. among interventions and outcomes. Opinion-based Evidence Guidelines I. Resource Preparation All opinion-based evidence relevant to each topic (e.g., survey data, openResource preparation includes (1) assessing the physical enviforum testimony, Internet-based comments, letters, editori- als) is ronment where central venous catheterization is planned to deconsidered in the development of these Guidelines. However, only the termine the feasibility of using aseptic techniques, (2) availabil- ity findings obtained fromformal surveys are reported. of a standardized equipment set, (3) use of an assistant for central Opinion surveys were developed by the Task Force to address each clinical intervention identified in the docu- ment. venous catheterization, and (4) use of a checklist or pro- tocol for Identical surveys were distributed to expert consul- tants and central venous catheter placement and maintenance. ASA members, and a survey addressing selected pediatric The literature is insufficient to specifically evaluate the effect of the physical environment for aseptic catheter inser- tion, issues was distributed to SPA members. availability of a standardized equipment set, or the use of an assistant on outcomes associated with central venous Category A: Expert Opinion catheterization (Category D evidence). An observational study Survey responses from Task Force-appointed expert consultants are reports that the implementation of a trauma intensive care reported in summary form in the text, with a complete listing of unit multidisciplinary checklist is associated with reduced consultant survey responses reported in appendix 5. catheter-related infection rates (Category B2 evidence).1 Observational studies report reduced catheter-related bloodstream infection rates when intensive care unit-wide bundled Category B: Membership Opinion Survey responses from active ASA and SPA members are re- protocols are implemented (Category B2 evidence).2–7 These ported in summary form in the text, with a complete listing of ASA studies do not permit the assessment of the effect of any and SPA member survey responses reported in appendix 5. single component of a checklist or bundled protocol on outcome. The Task Force notes that the use of checklists in other Survey responses are recorded using a 5-point scale and specialties or professions has been effective in reducing the summarized based on median values.§ error rate for a complex series of activities.8,9 Strongly Agree. Median score of 5 (at least 50% of the The consultants and ASA members strongly agree that cen- tral responses are 5). venous catheterization should be performed in a location that Agree. Median score of 4 (at least 50% of the responses are 4 or permits the use of aseptic techniques. The consultants and ASA members strongly agree that a standardized equipment set should 4 and 5). Equivocal. Median score of 3 (at least 50% of the responses are 3, be available for central venous access. The consultants and ASA or no other response category or com- bination of similar members agree that a trained assistant should be used during the placement of a central venous catheter. The ASA members categories contain at least 50% of the responses). agree and the consultants strongly agree that a check- list or § When an equal number of categorically distinct responses are obtained, protocol should be used for the placement and mainte- nance of the median value is determined by calculating the arith- metic mean of the two middle values. Ties are calculated by a predetermined central venous catheters. formula. Recommendations for Resource Preparation. Central veI Refer to appendix 2 for an example of a list of standardized nous catheterization should be performed in an environequipment for adult patients. ment that permits use of aseptic techniques. A standard# Refer to appendix 3 for an example of a checklist or protocol. ized equipment set should be available for central venous ** Refer to appendix 4 for an example of a list of duties per- formed access.I A checklist or protocol should be used for placeby an assistant. ment and maintenance of central venous catheters.# An assistant should be used during placement of a central venous catheter.** 17 Practice Guidelines 100%), caps (100% and 94.7%), and masks covering both the II. Prevention of Infectious Complications Interventions intended to prevent infectious complica- mouth and nose (100% and 98.1%). tions associated with central venous access include, but are not limited to (1) intravenous antibiotic prophylaxis, (2) aseptic techniques (i.e., practitioner aseptic preparation and patient Selection of Antiseptic Solution skin preparation), (3) selection of coated or impregnated Chlorhexidine solutions: A randomized controlled trial comcatheters, (4) selection of catheter insertion site, (5) catheter paring chlorhexidine (2% aqueous solution without alcohol) fixation method, (6) insertion site dress- ings, (7) catheter with 10% povidone iodine (without alcohol) for skin prepmaintenance procedures, and (8) aseptic techniques using an aration reports equivocal findings regarding catheter coloniexisting central venous catheter for injection or aspiration. zation (P 0.013) and catheter-related bacteremia (P 0.28) 13 Intravenous Antibiotic Prophylaxis. Randomized con- (Category C2 evidence). The literature is insufficient to trolled trials indicate that catheter-related infections and evaluate chlorhexidine with alcohol compared with povi- donesepsis are reduced when prophylactic intravenous antibi- iodine with alcohol (Category D evidence). The litera- ture is otics are administered to high-risk immunosuppressed insufficient to evaluate the safety of antiseptic solu- tions containing chlorhexidine in neonates, infants and children cancer patients or neonates. (Category A2 evidence).10,11 The (Category D evidence). literature is insufficient to evaluate outcomes associ- ated with the routine use of intravenous antibiotics (Cat- egory D Solutions containing alcohol: Comparative studies are insufficient to evaluate the efficacy of chlorhexidine with alco- hol evidence). in comparison with chlorhexidine without alcohol for skin The consultants and ASA members agree that intrave- nous preparation during central venous catheterization (Cat- egory D antibiotic prophylaxis may be administered on a case-byevidence). A randomized controlled trial of povidone- iodine with case basis for immunocompromised patients or high-risk alcohol indicates that catheter tip colonization is reduced when neonates. The consultants and ASA members agree that compared with povidone-iodine alone (Cate- gory A3 intravenous antibiotic prophylaxis should not be evidence); equivocal findings are reported for cathe- ter-related administered routinely. infection (P 0.04) and clinical signs of infection (P 0.09) Recommendations for Intravenous Antibiotic Prophylaxis. For (Category C2 evidence).14 immunocompromised patients and high-risk neonates, The consultants and ASA members strongly agree that administer intravenous antibiotic prophylaxis on a case-by- case chlorhexidine with alcohol should be used for skin prepbasis. Intravenous antibiotic prophylaxis should not be aration. SPA members are equivocal regarding whether administered routinely. chlorhexidine-containing solutions should be used for skin preparation in neonates (younger than 44 gestational weeks); they agree with the use of chlorhexidine in infants Aseptic Preparation and Selection of Antiseptic Solution (younger than 2 yr) and strongly agree with its use in Aseptic preparation of practitioner, staff, and patients: A ranchildren (2–16 yr). domized controlled trial comparing maximal barrier precau- tions (i.e., mask, cap, gloves, gown, large full-body drape) with a control group (i.e., gloves and small drape) reported Recommendations for Aseptic Preparation and Selection of equivocal findings for reduced colonization (P 0.03) and Antiseptic Solution catheter-related septicemia (P 0.06) (Category C2 evi- In preparation for the placement of central venous catheters, use dence).12 The literature is insufficient to evaluate the efficacy of aseptic techniques (e.g., hand washing) and maximal bar- rier specific aseptic activities (e.g., hand washing) or barrier precautions (e.g., sterile gowns, sterile gloves, caps, masks precautions (e.g., sterile full-body drapes, sterile gown, covering both mouth and nose, and full-body patient drapes). gloves, mask, cap) (Category D evidence). Observational stud- ies A chlorhexidine-containing solution should be used for skin report hand washing, sterile full-body drapes, sterile gloves, preparation in adults, infants, and children; for ne- onates, the caps, and masks as elements of care “bundles” that result in use of a chlorhexidine-containing solution for skin reduced catheter-related bloodstream infections (Category B2 preparation should be based on clinical judgment and evidence).2–7 However, the degree to which each particular element institutional protocol. If there is a contraindication to chlorhexidine, povidone-iodine or alcohol may be used. Unless contributed to improved outcomes could not be determined. Most consultants and ASA members indicated that the contraindicated, skin preparation solutions should contain following aseptic techniques should be used in preparation for alcohol. the placement of central venous catheters: hand washing (100% Catheters Containing Antimicrobial Agents. Meta-analysis of and 96%); sterile full-body drapes (87.3% and randomized controlled trials15–19 comparing antibiotic73.8%); sterile gowns (100% and 87.8%), gloves (100% and coated with uncoated catheters indicates that antibioticcoated catheters reduce catheter colonization (Category A1 evidence). Meta-analysis of randomized controlled trials20 –24 18 SPECIAL ARTICLES comparing silver-impregnated catheters with uncoated cath- eters Recommendations for Selection of Catheter Insertion Site. report equivocal findings for catheter-related blood- stream Catheter insertion site selection should be based on clininfection (Category C1 evidence); randomized con- trolled trials ical need. An insertion site should be selected that is not were equivocal regarding catheter colonization (P 0.16 – 0.82) contaminated or potentially contaminated (e.g., burned or (Category C2 evidence).20 –22,24 Meta-anal- yses of randomized infected skin, inguinal area, adjacent to tracheostomy or controlled trials25–36 demonstrate that catheters coated with open surgical wound). In adults, selection of an upper chlorhexidine and silver sulfadiazine reduce catheter body insertion site should be considered to minimize the colonization (Category A1 evidence); equivo- cal findings are risk of infection. Catheter Fixation. The literature is insufficient to evaluate reported for catheter-related bloodstream infection (i.e., catheter colonization and corresponding posi- tive whether catheter fixation with sutures, staples or tape is asblood culture) (Category C1 evidence).25–27,29 –35,37,38 Cases of sociated with a higher risk for catheter-related infections anaphylactic shock are reported after placement of a catheter (Category D evidence). coated with chlorhexidine and silver sulfadiazine (Category B3 Most consultants and ASA members indicate that use of evidence).39–41 sutures is the preferred catheter fixation technique to miniConsultants and ASA members agree that catheters coated with mize catheter-related infection. antibiotics or a combination of chlorhexidine and silver Recommendations for Catheter Fixation. The use of susulfadiazine may be used in selected patients based on infectious risk, tures, staples, or tape for catheter fixation should be detercost, and anticipated duration of catheter use. mined on a local or institutional basis. Recommendations for Use of Catheters Containing Anti- Insertion Site Dressings. The literature is insufficient to microbial Agents. Catheters coated with antibiotics or a evaluate the efficacy of transparent bio-occlusive dressings to combination of chlorhexidine and silver sulfadiazine should be reduce the risk of infection (Category D evidence). Ranused for selected patients based on infectious risk, cost, and domized controlled trials are equivocal (P 0.04 – 0.96) anticipated duration of catheter use. The Task Force notes that regarding catheter tip colonization50,51 and inconsistent (P catheters containing antimicrobial agents are not a substitute for 0.004 – 0.96) regarding catheter-related blood- stream additional infection precautions. infection50,52 when chlorhexidine sponge dressings are Selection of Catheter Insertion Site. A randomized con- compared with standard polyurethane dressings (Cate- gory trolled trial comparing the subclavian and femoral insertion sites C2 evidence). A randomized controlled trial is also equiv- ocal report higher levels of catheter colonization with the femoral regarding catheter tip colonization for silver-impreg- nated transparent dressings compared with standard dressings (P site (Category A3 evidence); equivocal findings are > 0.05) (Category C2 evidence).53 A randomized controlled trial reported for catheter-related sepsis (P 0.07) (Category C2 evidence).42 A randomized controlled trial comparing the in- reports a greater frequency of severe localized contact dermatitis ternal jugular insertion site with the femoral site reports no when neonates receive chlorhexidine-imdifference in catheter colonization (P 0.79) or catheter related pregnated dressings compared with povidone-iodine im54 bloodstream infections (P 0.42) (Category C2 evi- dence).43 pregnated dressings (Category A3 evidence). Prospective nonrandomized comparative studies are equivocal The ASA members agree and the consultants strongly agree (i.e., inconsistent) regarding catheter-related colonization44–46 that transparent bio-occlusive dressings should be used to and catheter related bloodstream infec- tion46–48 when the protect the site of central venous catheter insertion from internal jugular site is compared with the subclavian site infection. The consultants and ASA members agree that (Category C3 evidence). A nonrandomized comparative study dressings containing chlorhexidine may be used to reduce the risk of burn patients reports that catheter col- onization and of catheter-related infection. SPA members are equivocal bacteremia occur more frequently the closer the catheter regarding whether dressings containing chlorhexidine may be used for skin preparation in neonates (younger than 44 insertion site is to the burn wound (Category B1 evidence).49 gestational weeks); they agree that the use of dressings conMost consultants indicate that the subclavian insertion site is preferred to minimize catheter-related risk of infec- tion. Most taining chlorhexidine may be used in infants (younger than 2 yr) ASA members indicate that the internal jugular insertion site and children (2–16 yr). is preferred to minimize catheter-related risk of infection. Recommendations for Insertion Site Dressings. Transpar- ent The consultants and ASA members agree that femoral bio-occlusive dressings should be used to protect the site of catheterization should be avoided when pos- sible to central venous catheter insertion from infection. minimize the risk of infection. The consultants and ASA Unless contraindicated, dressings containing chlorheximembers strongly agree that an insertion site should be dine may be used in adults, infants, and children. For selected that is not contaminated or potentially contaminated. neonates, the use of transparent or sponge dressings containing chlorhexidine should be based on clinical judgment and institutional protocol. 19 Practice Guidelines Catheter Maintenance. Catheter maintenance consists of (1) connectors with standard caps indicate decreased levels of determining the optimal duration of catheterization, (2) con- microbial contamination of stopcock entry ports with needleless connectors (Category A2 evidence);63,64 no differducting catheter site inspections, (3) periodically changing ences in catheter-related bloodstream infection are reported (P catheters, and (4) changing catheters using a guidewire in0.3– 0.9) (Category C2 evidence).65,66 stead of selecting a new insertion site. The consultants and ASA members strongly agree that Nonrandomized comparative studies indicate that longer catheterizations are associated with higher rates of catheter catheter access ports should be wiped with an appropriate colonization, infection, and sepsis (Category B2 evi- antiseptic before each access. The consultants and ASA memdence).45,55 The literature is insufficient to evaluate whether bers agree that needleless ports may be used on a case-by-case specified time intervals between catheter site inspections are basis. The consultants and ASA members strongly agree that associated with a higher risk for catheter-related infection central venous catheter stopcocks should be capped when not in (Category D evidence). Randomized controlled trials report use. equivocal findings (P 0.54 – 0.63) regarding differences in Recommendations for Aseptic Techniques Using an Excatheter tip colonizations when catheters are changed at 3- isting Central Line. Catheter access ports should be wiped versus 7-day intervals (Category C2 evidence).56,57 Meta-anal- ysis with an appropriate antiseptic before each access when using an of randomized controlled trials58 – 62 report equivocal findings existing central venous catheter for injection or aspiration. for catheter tip colonization when guidewires are used to Central venous catheter stopcocks or access ports should be change catheters compared with the use of new in- sertion sites capped when not in use. Needleless catheter access ports may be used on a case-by-case basis. (Category C1 evidence). The ASA members agree and the consultants strongly agree III. Prevention of Mechanical Trauma or Injury that the duration of catheterization should be based on clinical Interventions intended to prevent mechanical trauma or need. The consultants and ASA members strongly agree that (1) the clinical need for keeping the catheter in place should injury associated with central venous access include, but be assessed daily; (2) catheters should be promptly removed are not limited to (1) selection of catheter insertion site, when deemed no longer clinically neces- sary; (3) the catheter site (2) positioning the patient for needle insertion and cathshould be inspected daily for signs of infection and changed when eter placement, (3) needle insertion and catheter placeinfection is suspected; and (4) when catheter infection is ment, and (4) monitoring for needle, guidewire, and cathsuspected, replacing the catheter using a new insertion site is eter placement. preferable to changing the cath- eter over a guidewire. 1. Selection of Catheter Insertion Site. A randomized conRecommendations for Catheter Maintenance. The dura- tion trolled trial comparing the subclavian and femoral insertion of catheterization should be based on clinical need. The clinical sites reports that the femoral site had a higher frequency of need for keeping the catheter in place should be asthrombotic complications in adult patients (Category A3 evsessed daily. Catheters should be removed promptly when no idence).42 A randomized controlled trial comparing the inlonger deemed clinically necessary. The catheter insertion site ternal jugular insertion site with the femoral site reports should be inspected daily for signs of infection, and the catheter equivocal findings for arterial puncture (P 0.35), deep should be changed or removed when catheter inser- tion site venous thrombosis (P 0.62) or hematoma formation (P 0.47) infection is suspected. When a catheter related in- fection is (Category C2 evidence).43 A randomized controlled trial suspected, replacing the catheter using a new inser- tion site is comparing the internal jugular insertion site with the subclavian site reports equivocal findings for successful venipreferable to changing the catheter over a guidewire. puncture (P 0.03) (Category C2 evidence).67 Nonrandomized comparative studies report equivocal findings for Aseptic Techniques Using an Existing Central Venous arterial puncture, pneumothorax, hematoma, hemothoCatheter for Injection or Aspiration rax, or arrhythmia when the internal jugular insertion site is compared with the subclavian insertion site (Category 68 –70 Aseptic techniques using an existing central venous catheter for C3 evidence). injection or aspiration consist of (1) wiping the port with an Most consultants and ASA members indicate that the appropriate antiseptic, (2) capping stopcocks or access ports, internal jugular insertion site is preferred to minimize catheter cannulation-related risk of injury or trauma. and (3) use of needleless catheter connectors or access ports. The literature is insufficient to evaluate whether wiping ports or Most consultants and ASA members also indicate that the capping stopcocks when using an existing central venous internal jugular insertion site is preferred to minimize catheter for injection or aspiration is associated with a reduced risk catheter-related risk of thromboembolic injury or trauma. for catheter-related infections (Category D evi- dence). Recommendations for Catheter Insertion Site Selection. Randomized controlled trials comparing needleless Catheter insertion site selection should be based on clinical need and practitioner judgment, experience, and 20 SPECIAL ARTICLES skill. In adults, selection of an upper body insertion site tion, and the skill and experience of the operator. The should be considered to minimize the risk of thrombotic consultants and ASA members agree that the selection of a complications. modified Seldinger technique versus a Seldinger technique 2. Positioning the Patient for Needle Insertion and Cath- should be based on the clinical situation and the skill and eter Placement. Nonrandomized studies comparing the Tren- experience of the operator. The consultants and ASA delenburg (i.e., head down) position with the normal supine members agree that the number of insertion attempts should be based on clinical judgment. The ASA members position indicates that the right internal jugular vein increases in diameter and cross-sectional area to a greater extent when adult agree and the consultants strongly agree that the decision to patients are placed in the Trendelenburg position (Category B2 place two central catheters in a single vein should be made evidence).71–76 One nonrandomized study comparing the Tren- on a case-by-case basis. delenburg position with the normal supine position in pediatric Recommendations for Needle Insertion, Wire Placement, patients reports an increase in right internal jugular vein diam- eter and Catheter Placement. Selection of catheter size (i.e., outside diameter) and type should be based on the clinical only for patients older than 6 yr (Category B2 evidence).77 The consultants and ASA members strongly agree that, when situation and skill/experience of the operator. Selection of clinically appropriate and feasible, central vascular ac- cess in the the smallest size catheter appropriate for the clinical situneck or chest should be performed with the patient in the ation should be considered. Selection of a thin-wall needle (i.e., Seldinger) technique versus a catheter-over-the-nee- dle Trendelenburg position. (i.e., modified Seldinger) technique should be based on the clinical situation and the skill/experience of the operator. Recommendations for Positioning the Patient for Needle The decision to use a thin-wall needle technique or a catheterover-the-needle technique should be based at least in part on Insertion and Catheter Placement When clinically appropriate and feasible, central venous ac- cess the method used to confirm that the wire resides in the vein in the neck or chest should be performed with the patient in the before a dilator or large-bore catheter is threaded (fig. 1). The Task Force notes that the catheter- over-the-needle Trendelenburg position. technique may provide more stable ve- nous access if 3. Needle Insertion, Wire Placement, and Catheter Placemanometry is used for venous confirmation. The number of ment. Needle insertion, wire placement, and catheter placeinsertion attempts should be based on clinical judgment. ment includes (1) selection of catheter size and type, (2) use of a wire- The decision to place two catheters in a single vein should be through-thin-wall needle technique (i.e., Seldinger tech- nique) made on a case-by-case basis. versus a catheter-over-the-needle-then-wire-through- the-catheter 4. Guidance and Verification of Needle, Wire, and Catheter technique (i.e., modified Seldinger technique), (3) limiting the Placement. Guidance for needle, wire, and catheter placement number of insertion attempts, and (4) introducing two catheters in includes ultrasound imaging for the purpose of prepuncture the same central vein. vessel localization (i.e., static ultrasound) and ultrasound for Case reports describe severe injury (e.g., hemorrhage, he- matoma, vessel localization and guiding the needle to its intended venous pseudoaneurysm, arteriovenous fistula, arterial dis- section, location (i.e., real time or dynamic ultrasound). Verification of neurologic injury including stroke, and severe or lethal airway needle, wire, or catheter location includes any one or more of the obstruction) when there is unintentional ar- terial cannulation following methods: (1) ultrasound, (2) manometry, (3) pressure with large bore catheters (Category B3 evidence).78–88 The waveform analysis, (4) venous blood gas, (5) fluoroscopy, (6) literature is insufficient to evaluate whether the risk of continuous electrocardiography, (7) transesophageal echocardiinjury or trauma is associated with the use of a thin-wall needle ography, and (8) chest radiography. technique versus a catheter-over- the needle technique (Category D evidence). The literature is insufficient to evaluate whether the risk of injury or trauma is related to Guidance the number of insertion attempts (Category D evidence). Static Ultrasound. Randomized controlled trials comparing One nonrandomized comparative study reports a higher static ultrasound with the anatomic landmark approach for lofrequency of dysrhythmia when two central venous catheters cating the internal jugular vein report a higher first insertion are placed in the same vein (right internal jugular) compared attempt success rate for static ultrasound (Category A3 evi90 with placement of one cathe- ter in the vein (Category B2 dence); findings are equivocal regarding overall successful can90 –92 In evidence); no differences in carotid artery puncture (P nulation rates (P 0.025– 0.57) (Category C2 evidence). 0.48) were noted (Category C3 addition, the literature is equivocal regarding subclavian vein 0.65) or hematoma (P access (P 0.84) (Category C2 evidence) 93 and insufficient for evidence).89 The consultants agree and the ASA members strongly agree femoral vein access (Category D evidence). that the selection of catheter type (i.e., gauge, length, The consultants and ASA members agree that static ultra- sound number of lumens) and composition (e.g., poly- urethane, imaging should be used in elective situations for pre- puncture identification of anatomy and vessel localization Teflon) should be based on the clinical situa- 21 Practice Guidelines Fig. 1. Algorithm for central venous insertion and verification. This algorithm compares the thin-wall needle (i.e., Seldinger) technique versus the catheter-over-the needle (i.e., Modified-Seldinger) technique in critical safety steps to prevent uninten- tional arterial placement of a dilator or largebore catheter. The variation between the two techniques reflects mitigation steps for the risk that the thin-wall needle in the Seldinger technique could move out of the vein and into the wall of an artery between the manometry step and the threading of the wire step. ECG electrocardiography; TEE transesophageal echocardiography. when the internal jugular vein is selected for cannulation; they Real-time Ultrasound. Meta-analysis of randomized conare equivocal regarding whether static ultrasound imag- ing trolled trials94 –104 indicates that, compared with the anashould be used when the subclavian vein is selected. The tomic landmark approach, real-time ultrasound guided veconsultants agree and the ASA members are equivocal re- nipuncture of the internal jugular vein has a higher first garding the use of static ultrasound imaging when the fem- oral insertion attempt success rate, reduced access time, higher overall successful cannulation rate, and decreased vein is selected. 22 SPECIAL ARTICLES rates of arterial puncture (Category A1 evidence). identifying the position of the catheter tip (Category B2 eviRandomized controlled trials report fewer number of insertion dence). Randomized controlled trials indicate that continuattempts with real-time ultrasound guided venipuncture of ous electrocardiography is effective in identifying proper the internal jugular vein (Category A2 evidence).97,99,103,104 catheter tip placement compared with not using electrocar115,126,127 For the subclavian vein, randomized controlled trials report fewer diography (Category A2 evidence). insertion attempts with real-time ultrasound guided veni- puncture The consultants and ASA members strongly agree that before (Category A2 evidence),105,106 and one randomized clinical trial insertion of a dilator or large- bore catheter over a wire, indicates a higher success rate and reduced access time, with fewer venous access should be confirmed for the catheter or thinarterial punctures and hematomas compared with the anatomic wall needle that accesses the vein. The Task Force be- lieves that blood color or absence of pulsatile flow should not be relied landmark approach (Category A3 evi- dence).106 upon to confirm venous access. The consultants agree and For the femoral vein, a randomized controlled trial re- ports a higher first-attempt success rate and fewer needle passes with ASA members are equivocal that venous access should be real-time ultrasound guided venipuncture com- pared with the confirmed for the wire that subsequently resides in the vein after anatomic landmark approach in pediatric patients (Category A3 traveling through a catheter or thin-wall needle before insertion of a dilator or large-bore catheter over a wire. The consultants and evidence).107 ASA members agree that, when feasible, both the location of the The consultants agree and the ASA members are equivocal that, when catheter or thin-wall needle and wire should be confirmed. available, real time ultrasound should be used for guidance during venous access when either the internal jugular or The consultants and ASA members agree that a chest femoral veins are selected for cannulation. The consultants and radiograph should be performed to confirm the location of the ASA members are equivocal regarding the use of real time catheter tip as soon after catheterization as clinically appropriate. They also agree that, for central venous catheters ultrasound when the subclavian vein is selected. placed in the operating room, a confirmatory chest radiograph may be performed in the early postoperative period. Verification The ASA members agree and the consultants strongly agree Confirming that the Catheter or Thin-wall Needle Resides in that, if a chest radiograph is deferred to the postoperative the Vein. A retrospective observational study reports that period, pressure waveform analysis, blood gas analysis, ultrasound, or fluoroscopy should be used to confirm venous manometrycan detect arterial punctures not identified by blood positioning of the catheter before use. 108 flow and color (Category B2 evidence). The literature is insufficient to address ultrasound, pressure-waveform analysis, blood gas analysis, blood color, or the absence of pulsatile flow as effective Recommendations for Guidance and Verification of Needle, methods of confirming catheter or thin-wall needle venous access Wire, and Catheter Placement The following steps are recommended for prevention of me(Category D evidence). chanical trauma during needle, wire, and catheter placement in Confirming Venous Residence of the Wire. An observational study elective situations: indicates that ultrasound can be used to confirm venous placement of the wire before dilation or final catheterization ● Use static ultrasound imaging before prepping and (Category B2 evidence).109 Case reports indicate that transesophdraping for prepuncture identification of anatomy to ageal echocardiography was used to identify guidewire position determine vessel localization and patency when the in(Category B3 evidence).110 –112 The literature is insufficient to ternal jugular vein is selected for cannulation. Static evaluate the efficacy of continuous electrocardiography in conultrasound may be used when the subclavian or femoral firming venous residence of the wire (Category D evidence), alvein is selected. though narrow complex electrocardiographic ectopy is recog● Use real time ultrasound guidance for vessel localization nized by the Task Force as an indicator of venous location of the wire. and venipuncture when the internal jugular vein is selected The literature is insufficient to address fluoroscopy as an effective for cannulation (see fig. 1). Real-time ultrasound may be method to confirm venous residence of the wire (Cat- egory D used when the subclavian or femoral vein is selected. The evidence); the Task Force believes that fluoroscopy may be used. Task Force recognizes that this approach may not be feaConfirming Residence of the Catheter in the Venous Sys- tem. sible in emergency circumstances or in the presence of Studies with observational findings indicate that fluoother clinical constraints. roscopy113,115 and chest radiography115–125 are useful in ● After insertion of a catheter that went over the needle or a thin-wall needle, confirm venous access.†† Methods for †† For neonates, infants, and children, confirmation of venous placement confirming that the catheter or thin-wall needle resides in may take place after the wire is threaded. the vein include, but are not limited to, ultrasound, manometry, pressure-waveform analysis, or venous blood gas measurement. Blood color or absence of pulsatile flow 23 Practice Guidelines should not be relied upon for confirming that the catheter or thin- nonsurgically, as follows: 54.9% (for neonates), 43.8% (for infants), and 30.0% (for children). SPA members indicating that the wall needle resides in the vein. ● When using the thin-wall needle technique, confirm catheter may be nonsurgically removed without consulta- tion is venous residence of the wire after the wire is threaded. as follows: 45.1% (for neonates), 56.2% (for infants), and 70.0% When using the catheter-over-the-needle technique, (for children). The Task Force agrees that the anesthesi- ologist confirmation that the wire resides in the vein may not be and surgeon should confer regarding the relative risks and needed (1) when the catheter enters the vein easily and benefits of proceeding with elective surgery after an arterial vessel manometry or pressure waveform measurement pro- has sustained unintended injury by a dilator or large-bore catheter. vides unambiguous confirmation of venous location of Recommendations for Management of Arterial Trauma or the catheter; and (2) when the wire passes through the Injury Arising from Central Venous Access. When unincatheter and enters the vein without difficulty. If there is tended cannulation of an arterial vessel with a dilator or any uncertainty that the catheter or wire resides in the large-bore catheter occurs, the dilator or catheter should be vein, confirm venous residence of the wire after the wire left in place and a general surgeon, a vascular surgeon, is threaded. Insertion of a dilator or large-bore catheter or an interventional radiologist should be immediately may then proceed. Methods for confirming that the wire consulted regarding surgical or nonsurgical catheter reresides in the vein include, but are not limited to, ultra- moval for adults. For neonates, infants, and children the sound (identification of the wire in the vein) or trans- decision to leave the catheter in place and obtain consulesophageal echocardiography (identification of the wire tation or to remove the catheter nonsurgically should be in the superior vena cava or right atrium), continuous based on practitioner judgment and experience. After the electrocardiography (identification of narrow-complex injury has been evaluated and a treatment plan has been ectopy), or fluoroscopy. executed, the anesthesiologist and surgeon should confer ● After final catheterization and before use, confirm resi- regarding relative risks and benefits of proceeding with the dence of the catheter in the venous system as soon as elective surgery versus deferring surgery to allow for a peclinically appropriate. Methods for confirming that the riod of patient observation. catheter is still in the venous system after catheterization and before use include manometry or pressure waveAppendix 1: Summary of Recommendations form measurement. ● Confirm the final position of the catheter tip as soon as Resource Preparation clinically appropriate. Methods for confirming the position of the catheter tip include chest radiography, fluoroscopy, or Central venous catheterization should be performed in an environment that permits use of aseptic techniques. continuous electrocardiography. For central venous catheters A standardized equipment set should be available for central veplaced in the operating room, perform the chest radiograph nous access. no later than the early postoperative period to confirm the A checklist or protocol should be used for placement and mainposition of the catheter tip. ● ● ● ● tenance of central venous catheters. An assistant should be used during placement of a central venous catheter. IV. Management of Arterial Trauma or Injury Arising from Central Venous Catheterization Case reports of adult patients with arterial puncture by a Prevention of Infectious Complications large bore catheter/vessel dilator during attempted central • For immunocompromised patients and high-risk neonates, venous catheterization indicate severe complications (e.g., administer intravenous antibiotic prophylaxis on a case-bycerebral infarction, arteriovenous fistula, hemothorax) af- ter case basis. immediate catheter removal; no such complications were o Intravenous antibiotic prophylaxis should not be adminisreported for adult patients whose catheters were left in place tered routinely. before surgical consultation and repair (Category B3 • In preparation for the placement of central venous catheters, use evidence).80,86 aseptic techniques (e.g., hand washing) and maximal barrier preThe consultants and ASA members agree that, when unin- tended cautions (e.g., sterile gowns, sterile gloves, caps, masks covering both mouth and nose, and full-body patient drapes). cannulation of an arterial vessel with a large-bore cathe- ter occurs, the catheter should be left in place and a general surgeon or • A chlorhexidine-containing solution should be used for skin preparation in adults, infants, and children. vascular surgeon should be consulted. When unin- tended cannulation of an arterial vessel with a large-bore cathe- ter occurs, o For neonates, the use of a chlorhexidine-containing solution for skin preparation should be based on clinical judgment and the SPA members indicate that the catheter should be left in place institutional protocol. and a general surgeon, vascular surgeon, or inter- ventional radiologist should be immediately consulted before deciding on whether to remove the catheter, either surgically or 24 SPECIAL ARTICLES o If there is a contraindication to chlorhexidine, povidone-iodine or alcohol may be used as alternatives. o Unless contraindicated, skin preparation solutions should contain alcohol. o In adults, selection of an upper body insertion site should be considered to minimize the risk of thrombotic complications. • When clinically appropriate and feasible, central venous access in the neck or chest should be performed with the patient in the Trendelenburg position. • If there is a contraindication to chlorhexidine, povidone-iodine or alcohol may be used. Unless contraindicated, skin preparation solutions should contain alcohol. • Selection of catheter size (i.e., outside diameter) and type should be based on the clinical situation and skill/experience of the operator. • Catheters coated with antibiotics or a combination of chlorhexidine and silver sulfadiazine should be used for selected patients based on infectious risk, cost, and anticipated duration of catheter use. o Catheters containing antimicrobial agents are not a substitute for additional infection precautions. o Selection of the smallest size catheter appropriate for the clinical situation should be considered. • Selection of a thin-wall needle (a wire-through-thin-wall-needle, or Seldinger) technique versus a catheter-over-the-needle (a catheter-over-the-needle-then-wire-through-the-catheter, or Modified Seldinger) technique should be based on the clinical situation and the skill/experience of the operator. • Catheter insertion site selection should be based on clinical need. o An insertion site should be selected that is not contaminated or potentially contaminated (e.g., burned or infected skin, inguinal area, adjacent to tracheostomy or open surgical wound). o In adults, selection of an upper body insertion site should be considered to minimize the risk of infection. • • • • • • • • o The decision to use a thin-wall needle technique or a catheter-over-the-needle technique should be based at least in part on the method used to confirm that the wire resides in the vein before a dilator or large-bore catheter is threaded. o The catheter-over-the-needle technique may provide The use of sutures, staples, or tape for catheter fixation should be more stable venous access if manometry is used for venous determined on a local or institutional basis. confirmation. Transparent bio-occlusive dressings should be used to protect • The number of insertion attempts should be based on clinical judgment. the site of central venous catheter insertion from infection. • The decision to place two catheters in a single vein should be o Unless contraindicated, dressings containing chlorhexidine made on a case-by-case basis. may be used in adults, infants, and children. o For neonates, the use of transparent or sponge dressings • Use static ultrasound imaging in elective situations before prepcontaining chlorhexidine should be based on clinical judgping and draping for prepuncture identification of anatomy to ment and institutional protocol. determine vessel localization and patency when the internal jugular vein is selected for cannulation. The duration of catheterization should be based on clinical o Static ultrasound may be used when the subclavian or femoral need. vein is selected. o The clinical need for keeping the catheter in place should be • Use real-time ultrasound guidance for vessel localization and assessed daily. venipuncture when the internal jugular vein is selected for o Catheters should be removed promptly when no longer cannulation. deemed clinically necessary. o Real-time ultrasound may be used when the subclavian or The catheter insertion site should be inspected daily for signs of femoral vein is selected. infection. o Real-time ultrasound may not be feasible in emergency o The catheter should be changed or removed when catheter circumstances or in the presence of other clinical insertion site infection is suspected. constraints. When a catheter-related infection is suspected, replacing the • After insertion of a catheter that went over the needle or a catheter using a new insertion site is preferable to changing the thin-wall needle, confirm venous access.†† catheter over a guidewire. o Methods for confirming that the catheter or thin-wall neeCatheter access ports should be wiped with an appropriate antidle resides in the vein include, but are not limited to: ultraseptic before each access when using an existing central venous sound, manometry, pressure-waveform analysis, or venous catheter for injection or aspiration. blood gas measurement. o Blood color or absence of pulsatile flow should not be relied Central venous catheter stopcocks or access ports should be upon for confirming that the catheter or thin-wall needle resides in capped when not in use. the vein. Needleless catheter access ports may be used on a case-by-case • When using the thin-wall needle technique, confirm venous resbasis. idence of the wire after the wire is threaded. • When using the catheter-over-the-needle technique, confirmation that the wire resides in the vein may not be needed (1) when the catheter enters the vein easily and manometry or pressure waveform measurement provides unambiguous con- Prevention of Mechanical Trauma or Injury • Catheter insertion site selection should be based on clinical need and practitioner judgment, experience, and skill. 25 Practice Guidelines firmation of venous location of the catheter, and (2) when the wire Appendix 2. Example of a Standardized Equipment Cart passes through the catheter and enters the vein without difficulty. for Central Venous Catheterization for Adult Patients o If there is any uncertainty that the catheter or wire resides in the Item Description Quantity vein, confirm venous residence of the wire after the wire is threaded. Insertion of a dilator or large-bore catheter may then proceed. First Drawer Bottles Alcohol-based Hand Cleanser 2 o Methods for confirming that the wire resides in the vein 2 include, but are not limited to surface ultrasound (identifi- cation of Transparent bio-occlusive dressings with catheter the wire in the vein) or transesophageal echocar- diography stabilizer devices 1 (identification of the wire in the superior vena cava or right Transducer kit: NaCL 0.9% 500 ml bag; singleatrium), continuous electrocardiography (identification of narrow- line transducer, pressure bag Needle Holder, Webster Disposable 5 inch 1 complex ectopy), or fluoroscopy. Scissors, 4 1/2 inchSterile 1 • After final catheterization and before use, confirm residence of Vascular Access Tray(Chloraprep, Sponges, 1 the catheter in the venous system as soon as clinically Labels) appropriate. Disposable pen with sterile labels 4 2 o Methods for confirming that the catheter is still in the Sterile tubing, arterial line pressure-rated (for venous system after catheterization and before use include manometry) Intravenous connector with needleless valve 4 waveform manometry or pressure measurement. Second Drawer • Confirm the final position of the catheter tip as soon as clinically appropriate. o Methods for confirming the position of the catheter tip include chest radiography, fluoroscopy, or continuous electrocardiography. • For central venous catheters placed in the operating room, perform the chest radiograph no later than the early postoperative period to confirm the position of the catheter tip. Management of Arterial Trauma or Injury Arising from Central Venous Catheterization Ultrasound Probe Cover, Sterile 3 x 96 Applicator, chloraprep 10.5 ml Surgical hair clipper blade Solution, NaCl bacteriostatic 30 ml 2 3 3 2 Third Drawer Cap, Nurses Bouffant Surgeon hats Goggles Mask, surgical fluidshield Gloves, sterile sizes 6.0–8.0 (2 each size) Packs, sterile gowns Fourth Drawer • When unintended cannulation of an arterial vessel with a dilator or large-bore catheter occurs, the dilator or catheter should be left Drape, Total Body (with Femoral Window) in place and a general surgeon, a vascular surgeon, or an interven- Sheet, central line total body (no window) tional radiologist should be immediately consulted regarding surFifth Drawer gical or nonsurgical catheter removal for adults. Dressing, Sterile Sponge Packages o For neonates, infants, and children, the decision to leave the Catheter kit, central venous pressure single catheter in place and obtain consultation or to remove the lumen14 gauge catheter nonsurgically should be based on practitioner judg- Catheter kits, central venous pressure two ment and experience. lumens 16 cm 7 French • After the injury has been evaluated and a treatment plan Sixth Drawer has been executed, the anesthesiologist and surgeon should confer regarding relative risks and benefits of proceeding with Triple Lumen Centravel Venous Catheter Sets, 7 French Antimicrobial Impregnated the elective surgery versus deferring surgery for a period of Introducer catheter sets, 9 French with sideport patient observation. 26 3 6 2 2 10 2 1 1 4 1 2 2 2 SPECIAL ARTICLES Appendix 3. Example of a Central Venous Catheterization Checklist Central Line Insertion Standard Work & Safety (Bundle) Checklist for OR and CCU Date: Start Time: Procedure Operator: Person Completing Form: D Central Venous Catheter Type: End Time: D PA/Swan-Ganz French Size of catheter: Catheter lot number: Number of Lumens: Insertion Site: D1 D2 D Jugular D3 D4 D Upper Arm D Subclavian D Femoral Side of Body: D Left D Right Clinical Setting: D Elective D Emergent D Bilateral 1. Consent form complete and in chart Exception: Emergent procedure D 2. Patient’s Allergy Assessed (especially to Lidocaine or Heparin) D 3. Patient’s Latex Allergy Assessed (modify supplies) D 4. Hand Hygiene: D Operator and Assistant cleanse hands (ASK, if not witnessed) D 5. Optimal Catheter Site Selection: D In adults, Consider Upper Body Site D Check / explain why femoral site used: D Anatomy – distorted, prior surgery/rad. Scar D Coagulopathy D Emergency / CPR D D D Chest wall infection or burn D COPD severe/ lung disease D Pediatric 6. Pre-procedure Ultrasound Check of internal jugular location and patency if IJ OR Exception(s) checked to left D 7. Skin Prep Performed (Skin Antisepsis): D Chloraprep 10.5 ml applicator used D Dry technique (normal, unbroken skin): 30 second scrub + 30 second dry D D DRY D WET time D Wet technique (abnormal or broken skin): 2 minute scrub + 1 minute dry time 8. MAXIMUM Sterile Barriers: D Operator wearing hat, mask, sterile gloves, and sterile gown D Others in room, (except patient) wearing mask D Patient’s body covered by sterile drape 9. Procedural “Time out” performed: D Patient ID X 2 D Procedure to be performed has been announced D Insertion site marked D Patient positioned correctly for procedure (Supine or Trendelenburg) D Assembled equipment/ supplies including venous confirmation method verified D Labels on all medication & syringes are verified D D D D D D D D D (continued) 27 Practice Guidelines Appendix 3. Continued 10. Ultrasound Guidance Used for Elective Internal Jugular insertions (sterile probe cover in place) 11. Confirmation of Venous Placement of Access Needle or Catheter: (do not rely on blood color or presence/absence of pulsatility) D Used for IJ D Not used (Other site used) D Manometry D Ultrasound D Transducer D Blood Gas 12. Confirmation of Venous Placement of the Wire: D Access catheter easily in vein & confirmed (catheter-over needle technique) D Not Needed D Access via thin-wall needle (confirmation of wire recommended) D or ambiguous catheter or wire placement when using catheter-over-the-needle D Ultrasound D TEE D Fluoroscopy D ECG technique 13. Confirmation of Final Catheter in Venous System Prior to Use: D Manometry D Transducer 14. Final steps: D D D D D Verify guidewire not retained Type and Dosage (ml / units) of Flush: Catheter Caps Placed on Lumens Tip position confirmation: Fluoroscopy Chest radiograph ordered D D D D D D Catheter Secured / Sutured in place 15. Transparent Bio-occlusive dressing applied D 16. Sterile Technique Maintained when applying dressing D 17. Dressing Dated D D CXR D Fluoroscopy D Continuous 18. Confirm Final Location of Catheter Tip ECG 19. After tip location confirmed, “Approved for use” Written on Dressing D 20. Central line (maintenance) Order Placed D Comments: Tip location: 28 Appendix 4. Example Duties Performed by an Assistant for Central Venous Catheterization Reads prompts on checklist to ensure that no safety step is forgotten or missed. Completes checklist as task is completed Verbally alerts anesthesiologist if a potential error or mistake is about to be made. Gathers equipment/supplies or brings standardized supply cart. Brings the ultrasound machine, positions it, turns it on, makes adjustments as needed. Provides moderate sedation (if registered nurse) if needed. Participates in “time-out” before procedure. Washes hands and wears mask, cap, and nonsterile gloves (scrubs or cover gown required if in the sterile envelope). Attends to patient requests if patient awake during procedure. Assists with patient positioning. Assists with draping. Assists with sterile field setup; drops sterile items into field as needed. Assists with sterile ultrasound sleeve application to ultrasound probe. Assists with attachment of intravenous lines or pressure lines if needed. Assists with application of a sterile bandage at the end of the procedure. Assists with clean-up of patient, equipment, and supply cart; returns items to their proper location. Appendix 5: Methods and Analyses State of the Literature For these Guidelines, a literature review was used in combination with opinions obtained from expert consultants and other sources (e.g., ASA members, SPA members, open forums, Internet post- ings). Both the literature review and opinion data were based on evidence linkages, or statements regarding potential relationships between clinical interventions and outcomes. The interventions listed below were examined to assess their effect on a variety of outcomes related to central venous catheterization. Resource Preparation Selection of a Sterile Environment Availability of a standardized equipment set Use of a checklist or protocol for placement and maintenance Use of an assistant for placement Prevention of Infectious Complications Intravenous antibiotic prophylaxis Aseptic techniques Aseptic preparation Hand washing, sterile full-body drapes, sterile gown, gloves, mask, cap Skin preparation Chlorhexidine versus povidone-iodine Aseptic preparation with versus without alcohol Selection of catheter coatings or impregnation Antibiotic-coated catheters versus no coating Silver-impregnated catheters versus no coating Chlorhexidine combined with silver sulfadiazine catheter coating versus no coating Selection of catheter insertion site Internal jugular Subclavian Femoral Selecting a potentially uncontaminated insertion site Catheter fixation Suture, staple, or tape Insertion site dressings Clear plastic, chlorhexidine, gauze and tape, cyanoacrylate, antimicrobial dressings, patch, antibiotic ointment Catheter maintenance Long-term versus short-term catheterization Frequency of insertion site inspection for signs of infection Changing catheters Specified time intervals Specified time interval versus no specified time interval (i.e., as needed) One specified time interval versus another specified time interval Changing a catheter over a wire versus a new site Aseptic techniques using an existing central line for injection or aspiration Wiping ports with alcohol Capping stopcocks Needleless connectors or access ports Prevention of Mechanical Trauma or Injury Selection of catheter insertion site Internal jugular Subclavian Femoral Trendelenburg versus supine position Needle insertion and catheter placement Selection of catheter type (e.g., double lumen, triple lumen, Cordis) Selection of a large-bore catheter Placement of two catheters in the same vein Use of a Seldinger technique versus a modified Seldinger technique Limiting number of insertion attempts Guidance of needle, wire and catheter placement Static ultrasound versus no ultrasound (i.e., anatomic landmarks) Real-time ultrasound guidance versus no ultrasound Verification of placement Manometry versus direct pressure measurement (via pressure transducer) Continuous electrocardiogram Fluoroscopy Venous blood gas Transesophageal echocardiography Chest radiography Management of Trauma or Injury Arising from Central Venous Catheterization Not removing versus removing central venous catheter on evidence of arterial puncture. 29 Practice Guidelines For the literature review, potentially relevant clinical studies were 0.70, Var (Sav) 0.016; (3) linkage assignment, Sav 0.94, Var (Sav) identified via electronic and manual searches of the literature. The 0.002; (4) literature database inclusion, Sav 0.65, Var (Sav) 0.034. electronic and manual searches covered a 44-yr period from 1968 These values represent moderate to high levels of agreement. through 2011. More than 2,000 citations were initially identified, yielding a total of 671 nonoverlapping articles that addressed topics Consensus-based Evidence related to the evidence linkages. After review of the articles, 383 Consensus was obtained from multiple sources, including (1) sur- vey studies did not provide direct evidence, and were subsequently opinion from consultants who were selected based on their eliminated. A total of 288 articles contained direct linkage-related knowledge or expertise in central venous access, (2) survey opinions evidence. A complete bibliography used to develop these Guide- lines, solicited from active members of the ASA and SPA, (3) testimony organized by section, is available as Supplemental Digital Content 2, from attendees of publicly-held open forums at two national aneshttp://links.lww.com/ALN/A784. thesia meetings, (4) Internet commentary, and (5) task force opin- ion Initially, each pertinent outcome reported in a study was classi- fied as and interpretation. The survey rate of return was 41.0% (n 55 of 134) supporting an evidence linkage, refuting a linkage, or equiv- ocal. The for the consultants (table 2), 530 surveys were received from active results were then summarized to obtain a directional assessment for ASA members (table 3), and 251 surveys were received from active each evidence linkage before conducting formal meta-analyses. SPA members (table 4). Literature pertaining to five evidence linkages con- tained enough An additional survey was sent to the expert consultants asking them studies with well-defined experimental designs and statistical to indicate which, if any, of the evidence linkages would change information sufficient for meta-analyses (table 1). These linkages were their clinical practices if the Guidelines were instituted. The rate of (1) antimicrobial catheters, (2) silver sulfadiazine catheter coatings, (3) return was 16% (n 22 of 134). The percentage of respond- ing chlorhexidine and silver sulfadiazine catheter coatings, (4) changing a consultants expecting no change associated with each linkage were as follows: (1) availability of a standardized equipment set 91.8%, (2) catheter over a wire versus a new site, and use of a trained assistant 83.7%, (3) use of a checklist or protocol for (5) ultrasound guidance for venipuncture. General variance-based effect-size estimates or combined prob- ability placement and maintenance 75.5%, (4) use of bundles that include a tests were obtained for continuous outcome measures, and Mantel- checklist or protocol 87.8%, (5) intravenous antibiotic prophylaxis Haenszel odds-ratios were obtained for dichotomous out- come 93.9%, (6) aseptic preparation (e.g., hand washing, caps, masks) 98.0%, measures. Two combined probability tests were employed as follows: (1) (8) skin preparation 98.0%, (9) selection of cath- eters with antibiotic or the Fisher combined test, producing chi-square values based on antiseptic coatings/impregnation 89.8%, logarithmic transformations of the reported P values from the (10) selection of catheter insertion site for prevention of infection independent studies, and (2) the Stouffer combined test, pro- viding 100%, (11) catheter fixation methods 89.8%, (12) insertion site weighted representation of the studies by weighting each of the standard dressings 100%, (13) catheter maintenance 100%, (14) aseptic normal deviates by the size of the sample. An odds- ratio procedure techniques using an existing central line for injection or aspiration based on the Mantel-Haenszel method for combin- ing study results 95.9%, (15) selection of catheter insertion site for prevention of meusing 2 x 2 tables was used with outcome fre- quency information. An chanical trauma or injury 100%, (16) Trendelenburg versus supine acceptable significance level was set at P < patient positioning for neck or chest venous access 100%, (17) needle 100%, (18) guidance of needle, 0.01 (one-tailed). Tests for heterogeneity of the independent stud- ies insertion and catheter placement were conducted to assure consistency among the study results. wire, and catheter placement 89.8%, (19) verification of needle puncture DerSimonian-Laird random-effects odds ratios were obtained when and placement 98.0%, (20) management of trauma or injury 100%. significant heterogeneity was found (P < 0.01). To control for Fifty-seven percent of the respondents indicated that the Guide- lines potential publishing bias, a “fail-safe n ” value was calculated. No would have no effect on the amount of time spent on a typical case, search for unpublished studies was conducted, and no reliability tests for and 43% indicated that there would be an increase of the amount locating research results were done. To be accepted as significant of time spent on a typical case with the implementation of these findings, Mantel-Haenszel odds ratios must agree with combined test Guidelines. Seventy-four percent indicated that new equip- ment, results whenever both types of data are assessed. In the absence of supplies, or training would not be needed to implement the Mantel-Haenszel odds-ratios, findings from both the Fisher and Guidelines, and 78% indicated that implementation of the Guideweighted Stouffer combined tests must agree with each other to be lines would not require changes in practice that would affect costs. acceptable as significant. Interobserver agreement among Task Force members and two Combined Sources of Evidence methodologists was established by interrater reliability testing. Evidence for these Guidelines was formally collected from multiple Agreement levels using a kappa (K) statistic for two-rater agreement pairs sources, including randomized controlled trials, observational literwere as follows: (1) type of study design, K 0.70 –1.00l; (2) type of ature, surveys of expert consultants, and randomly selected samples of analysis, K 0.60 – 0.84; (3) evidence linkage assignment, K 0.91– ASA and SPA members. This information is summarized in table 5, 1.00; and (4) literature inclusion for database, K 0.65– with a brief description of each corresponding recommendation. 1.00. Three-rater chance-corrected agreement values were (1) study design, Sav 0.80, Var (Sav) 0.006; (2) type of analysis, Sav 30 SPECIAL ARTICLES Table 1. Meta-analysis Summary Evidence Linkages N Antibiotic-coated catheters vs. no coating 5 Catheter colonization Silver sulfadiazine catheter coating vs. no coating 5 Catheter-related bloodstream infection Chlorhexidine + silver sulfadiazine catheter coating vs. no coating Catheter colonization 12 Catheter-related 12 bloodstream infection Changing a catheter over a wire vs. a new site Catheter colonization 5 Real-time ultrasound guidance vs. no ultrasound* Successful insertion/ 11 cannulation 5 First attempt success Time to insertion 6 Arterial puncture 10 Fisher Chisquare Heterogeneity Weighted P Stouffer P Effect Odds Confidence Value Zc Value Size Ratio Interval P Effect Values Size 0.35 0.23–0.55 ns 0.70 0.45–1.10 ns 0.43 0.34–0.54 0.70 0.47–1.03 ns ns 1.18 ns 0.66–2.09 7.15† 1.33–18.27 3.24 70.67 0.001 -7.15 0.001 0.005 1.93–5.45 -0.23 ns 0.24 0.15–0.38 ns ns ns * Findings represent studies addressing internal jugular access. † Random-effects odds ratio. ns P > 0.01. Table 2. Consultant Survey Responses* Percent Responding to Each Item Strongly Agree Agree Equivocal N I. Resource preparation 1. Central venous catheterization should be performed in a location that permits the use of aseptic techniques 2. A standardized equipment set should be available for central venous access 3. A trained assistant should be present during placement of a central venous catheter 4. A checklist or protocol should be used for the placement and maintenance of central venous catheters II. Prevention of infectious complications 5. Intravenous antibiotic prophylaxis should not be administered routinely 6. For immunocompromised patients and high-risk neonates, intravenous antibiotic prophylaxis may be administered on a case-by-case basis 7. The practitioner should use the following aseptic techniques in preparation for the placement of central venous catheters (check all that apply) Hand washing Sterile full-body drapes Sterile gowns Gloves Caps Masks covering both mouth and nose 54 92.6* 7.4 55 78.2* 16.4 54 33.3 29.6* 54 59.3* 20.4 Disagree Strongly Disagree 0.0 0.0 0.0 5.4 0.0 0.0 18.4 1.9 9.3 1.8 16.7 9.3 55 43.6 32.7* 12.7 7.3 3.6 55 23.6 36.4* 27.3 10.9 1.8 55 Percentage 100.0 87.3 100.0 100.0 100.0 100.0 (continued) 31 Practice Guidelines Table 2. Continued Percent Responding to Each Item N 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. Chlorhexidine with alcohol should be used for skin preparation Catheters coated with antibiotics or a combination of chlorhexidine and silver sulfadiazine may be used in selected patients based on infectious risk, cost, and anticipated duration of catheter use Please indicate your preferred central venous catheter insertion site to minimize catheterrelated risk of infection (check one) Internal jugular Subclavian Femoral No preference Femoral catheterization should be avoided when possible to minimize the risk of infection An insertion site should be selected that is not contaminated or potentially contaminated (e.g., burned or infected skin, inguinal area, adjacent to tracheostomy or open surgical wound) Please indicate your preferred catheter fixation technique to minimize catheter-related risk of infection (check one) Sutures Staples Tape No preference Transparent bio-occlusive dressings should be used to protect the site of central venous catheter insertion from infection Dressings containing chlorhexidine may be used to reduce the risk of catheter-related infection The duration of catheterization should be based on clinical need The clinical need for keeping a catheter in place should be assessed daily Catheters should be promptly removed when deemed no longer clinically necessary The catheter site should be inspected daily for signs of infection The catheter should be changed or removed when infection is suspected When catheter-related infection is suspected, replacing the catheter using a new insertion site is preferable to changing the catheter over a guidewire Catheter access ports should be wiped with an appropriate antiseptic before each access Needleless catheter access ports may be used on a case-by-case basis Central venous catheter stopcocks should be capped when not in use Strongly Agree Agree Equivocal 55 72.7* 27.3 0.0 0.0 0.0 45.5* 16.3 0.0 0.0 54 Percentage 41.8 52.7 0.0 5.5 37.0 53.7* 3.7 3.7 1.9 53 71.7* 24.5 7.8 0.0 0.0 54 Percentage 70.4 3.7 5.5 20.4 52.7* 41.8 3.6 1.8 0.0 34.6* 45.4 0.0 0.0 55 55 55 55 38.2 20.0 Strongly Disagree Disagree 55 61.8* 30.9 0.0 7.3 0.0 53 90.6* 9.4 0.0 0.0 0.0 54 88.9* 11.1 0.0 0.0 0.0 54 88.9* 11.1 0.0 0.0 0.0 55 74.6* 20.0 3.6 1.8 0.0 55 70.9* 27.3 1.8 0.0 0.0 55 69.1* 21.8 7.3 1.8 0.0 47.3* 12.7 3.6 5.5 18.5 0.0 0.0 0.0 55 54 30.9 81.5* (continued) 32 SPECIAL ARTICLES Table 2. Continued Percent Responding to Each Item Strongly N III. Prevention of mechanical trauma or injury 25. Please indicate your preferred central venous catheter insertion site to minimize catheter cannulation-related risk of injury or trauma (check one) Internal jugular Subclavian Femoral No preference 26. Please indicate your preferred central venous catheter insertion site to minimize catheterrelated risk of thromboembolic injury or trauma (check one) Internal jugular Subclavian Femoral No preference 27. When clinically appropriate and feasible, central venous access in the neck or chest should be performed in the Trendelenburg position 28. Selection of catheter type (i.e., gauge, length, number of lumens) and composition (e.g., polyurethane, Teflon) should be based on the clinical situation and skill/experience of the operator 29. Selection of a modified Seldinger technique vs. a Seldinger technique should be based on the clinical situation and the skill/experience of the operator 30. The number of insertion attempts should be based on clinical judgment 31. The decision to place two catheters in a single vein should be made on a case-by-case basis 32. Ultrasound imaging (i.e., static) should be used in elective situations for pre-puncture identification of anatomy and vessel localization when the internal jugular vein is selected for cannulation 33. Ultrasound imaging (i.e., static) should be used in elective situations for pre-puncture identification of anatomy and vessel localization when the subclavian vein is selected for cannulation 34. Ultrasound imaging (i.e., static) should be used in elective situations for pre-puncture identification of anatomy and vessel localization when the femoral vein is selected for cannulation 35. When available, real-time ultrasound should be used for guidance during venous access when the internal jugular vein is selected for cannulation 36. When available, real-time ultrasound should be used for guidance during venous access when the subclavian vein is selected for cannulation Agree Agree Equivocal Strongly Disagree Disagree 55 Percentage 81.8 9.1 3.6 5.6 55 54 Percentage 76.4 7.3 0.0 16.3 51.9* 33.3 9.6 5.6 0.0 55 49.1 38.2* 9.1 3.6 0.0 55 36.4 49.1* 5.4 7.3 1.8 55 45.5 32.7* 3.6 16.4 1.8 55 55.6* 40.0 3.6 1.8 0.0 53 49.1 26.4* 11.3 9.4 3.8 55 12.7 18.2 32.7* 25.5 10.9 55 18.2 32.7* 21.8 23.6 3.6 54 44.4 33.3* 13.0 9.3 0.0 53 11.3 17.0 37.7* 28.3 5.7 (continued) 33 Practice Guidelines Table 2. Continued Percent Responding to Each Item N 37. When available, real-time ultrasound should be 54 used for guidance during venous access when the femoral vein is selected for cannulation 38. Before insertion of a dilator or large bore 54 catheter over a wire, venous access should be confirmed for the catheter or thin-wall needle that accesses the vein 39. Before insertion of a dilator or large bore 55 catheter over a wire, venous access should be confirmed for the wire that subsequently resides in the vein after traveling through a catheter or thin-wall needle 40. When feasible, both the location of the catheter 55 or thin-wall needle and wire should be confirmed 41. A chest radiograph should be performed to 55 confirm the location of the catheter tip as soon after catheterization as clinically appropriate 42. For central venous catheters placed in the 55 operating room, a confirmatory chest radiograph may be performed in the early postoperative period 43. If a chest radiograph will be deferred to the 55 postoperative period, pressure/waveform analysis, blood gas analysis, ultrasound or fluoroscopy should be used to confirm venous positioning of the catheter before use IV. Management of arterial trauma or injury arising from central venous 44. When unintended cannulation of an arterial 55 vessel with a large bore catheter occurs, the catheter should be left in place and a general or vascular surgeon should be consulted *N Strongly Agree Agree Equivocal Strongly Disagree Disagree 14.8 35.2* 33.3 14.8 1.9 57.4* 25.9 7.4 9.3 0.0 29.1 29.1* 25.5 12.7 3.6 25.4 38.2* 18.2 15.6 3.6 30.9 41.8* 9.1 14.5 3.6 47.3 50.9* 0.0 1.8 0.0 56.4* 30.9 5.4 7.3 0.0 45.4 36.4* 7.3 number of consultants who responded to each item. An asterisk next to a percentage score indicates the median. 34 9.1 1.8 SPECIAL ARTICLES Table 3. ASA Member Survey Responses* Percent Responding to Each Item Strongly N I. Resource preparation 1. Central venous catheterization should be performed in a location that permits the use of aseptic techniques 2. A standardized equipment set should be available for central venous access 3. A trained assistant should be present during placement of a central venous catheter 4. A checklist or protocol should be used for The placement and maintenance of central venous catheters II. Prevention of infectious complications 5. Intravenous antibiotic prophylaxis should not be administered routinely 6. For immunocompromised patients and high-risk neonates, intravenous antibiotic prophylaxis may be administered on a case-by-case basis 7. The practitioner should use the following aseptic techniques in preparation for the placement of central venous catheters (check all that apply) Hand washing Sterile full-body drapes Sterile gowns Gloves Caps Masks covering both mouth and nose 8. Chlorhexidine with alcohol should be used for skin preparation 9. Catheters coated with antibiotics or a combination of chlorhexidine and silver sulfadiazine may be used in selected patients based on infectious risk, cost, and anticipated duration of catheter use 10. Please indicate your preferred central venous catheter insertion site to minimize catheterrelated risk of infection (check one) Internal jugular Subclavian Femoral No preference 11. Femoral catheterization should be avoided when possible to minimize the risk of infection 12. An insertion site should be selected that is not contaminated or potentially contaminated (e.g., burned or infected skin, inguinal area, adjacent to tracheostomy or open surgical wound) Agree Agree Equivocal Strongly Disagree Disagree 529 78.1* 19.1 2.1 0.8 0.0 530 64.5* 30.0 4.2 0.9 0.4 526 24.1 35.6* 24.0 13.1 3.2 528 35.6 37.5* 16.3 8.9 1.7 526 29.7 44.5* 16.9 7.0 1.9 523 25.0 54.1* 15.9 4.2 0.8 524 Percentage 96.0 73.8 87.8 100.0 94.7 0.8 0.0 1.7 0.0 98.1 522 57.3* 34.1 526 24.3 54.8* 524 525 Percentage 51.3 44.3 0.0 4.4 33.9 49.7* 9.3 4.7 2.3 523 58.9* 37.9 2.5 0.7 0.0 7.8 19.2 (continued) 35 Practice Guidelines Table 3. Continued Percent Responding to Each Item Strongly Agree Please indicate your preferred catheter fixation technique to minimize catheterrelated risk of infection (check one) Sutures Staples Tape No preference 14. Transparent bio-occlusive dressings should be used to protect the site of central venous catheter insertion from infection 15. Dressings containing chlorhexidine may be used to reduce the risk of catheter-related infection 16. The duration of catheterization should be based on clinical need 17. The clinical need for keeping a catheter in place should be assessed daily 18. Catheters should be promptly removed when deemed no longer clinically necessary 19. The catheter site should be inspected daily for signs of infection 20. The catheter should be changed or removed when infection is suspected 21. When catheter-related infection is suspected, replacing the catheter using a new insertion site is preferable to changing the catheter over a guidewire 22. Catheter access ports should be wiped with an appropriate antiseptic before each access 23. Needleless catheter access ports may be used on a case-by-case basis 24. Central venous catheter stopcocks should be capped when not in use III. Prevention of mechanical trauma or injury 25. Please indicate your preferred central venous catheter insertion site to minimize catheter cannulation-related risk of injury or trauma (check one) Internal jugular Subclavian Femoral No preference 26. Please indicate your preferred central venous catheter insertion site to minimize catheter-related risk of thromboembolic injury or trauma (check one) Internal jugular Subclavian Femoral No preference Agree Equivocal Percentage 80.2 5.7 3.6 10.5 46.9 N 44.4* 6.5 1.3 0.8 Disagree Strongly Disagree 13. 524 522 525 18.7 37.9* 41.3 1.9 0.2 523 49.5 44.5* 3.1 2.5 0.4 523 65.8* 32.5 1.3 0.4 0.0 521 78.7* 20.9 0.4 0.0 0.0 521 79.1* 19.6 1.1 0.2 0.0 524 72.7* 24.4 2.5 0.2 0.2 525 64.8* 30.7 3.8 0.8 0.0 522 64.6* 31.0 3.4 1.0 0.0 51.3* 12.3 1.7 0.8 26.2 2.6 0.6 0.0 522 33.9 527 70.6* 525 Percentage 79.4 10.7 2.7 7.2 525 Percentage 67.6 12.8 1.9 17.7 (continued) 36 SPECIAL ARTICLES Table 3. Continued Percent Responding to Each Item Strongly Agree Agree 528 57.0* 37.7 3.0 1.9 0.4 530 52.1* 38.1 6.2 3.4 0.0 531 47.8 36.9* 9.8 4.7 0.8 528 47.3 43.6* 4.2 3.8 1.1 527 45.9 36.2* 12.1 4.4 1.3 526 28.9 25.1* 21.3 18.8 5.9 528 9.7 14.2 41.5* 26.5 8.1 527 11.9 29.8 30.6* 21.4 6.3 525 24.0 24.2 23.2* 21.5 7.1 530 8.1 13.4 42.1* 27.9 8.5 528 13.5 23.5 31.4* 25.0 6.6 524 52.9* 32.1 6.3 0.4 524 24.0 25.4 22.9 2.1 N 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. When clinically appropriate and feasible, central venous access in the neck or chest should be performed in the Trendelenburg position Selection of catheter type (i.e., gauge, length, number of lumens) and composition (e.g., polyurethane, Teflon) should be based on the clinical situation and skill/experience of the operator Selection of a modified Seldinger technique vs. a Seldinger technique should be based on the clinical situation and the skill/experience of the operator The number of insertion attempts should be based on clinical judgment The decision to place two catheters in a single vein should be made on a case-bycase basis Ultrasound imaging (i.e., static) should be used in elective situations for pre-puncture identification of anatomy and vessel localization when the internal jugular vein is selected for cannulation Ultrasound imaging (i.e., static) should be used in elective situations for pre-puncture identification of anatomy and vessel localization when the subclavian vein is selected for cannulation Ultrasound imaging (i.e., static) should be used in elective situations for pre-puncture identification of anatomy and vessel localization when the femoral vein is selected for cannulation When available, real time ultrasound should be used for guidance during venous access when the internal jugular vein is selected for cannulation When available, real time ultrasound should be used for guidance during venous access when the subclavian vein is selected for cannulation When available, real-time ultrasound should be used for guidance during venous access when the femoral vein is selected for cannulation Before insertion of a dilator or large bore catheter over a wire, venous access should be confirmed for the catheter or thin-wall needle that accesses the vein Before insertion of a dilator or large bore catheter over a wire, venous access should be confirmed for the wire that subsequently resides in the vein after traveling through a catheter or thin-wall needle Equivocal 8.4 25.6* Strongly Disagree Disagree (continued) 37 Practice Guidelines Table 3. Continued Percent Responding to Each Item Strongly Agree Equivocal Disagree Strongly Disagree 32.5* 22.1 19.4 2.3 39.8 45.5* 7.1 7.0 0.6 46.8 48.1* 2.5 1.9 0.8 33.0 When feasible, both the location of the 526 catheter or thin-wall needle and wire should be confirmed 41. A chest radiograph should be performed 525 to confirm the location of the catheter tip as soon following catheterization as clinically appropriate 42. For central venous catheters placed in the 524 operating room, a confirmatory chest radiograph may be performed in the early postoperative period 43. If a chest radiograph will be deferred to 527 the postoperative period, pressure/waveform analysis, blood gas analysis, ultrasound or fluoroscopy should be used to confirm venous positioning of the catheter before use IV. Management of arterial trauma or injury arising from central venous 44. When unintended cannulation of an 526 arterial vessel with a large bore catheter occurs, the catheter should be left in place and a general or vascular surgeon should be consulted 40. Agree 23.8 N 35.3* 12.7 16.7 2.3 28.5 35.6* 16.3 17.9 * Number of ASA members who responded to each item. An asterisk next to a percentage score indicates the median. 38 1.7 SPECIAL ARTICLES Table 4. SPA Member Survey Responses* Percent Responding to Each Item N 1. A chlorhexidine-containing solution should be used for skin preparation in neonates† 2. A chlorhexidine-containing solution should be used for skin preparation in infants‡ 3. A chlorhexidine-containing solution should be used for skin preparation in children§ 4. Dressings containing chlorhexidine may be used in neonates 5. Dressings containing chlorhexidine may be used in infants 6. Dressings containing chlorhexidine may be used in children 7. When unintended cannulation of an arterial vessel with a large bore catheter occurs in neonates (check one) The catheter should be left in place5 The catheter may be nonsurgically removedI 8. When unintended cannulation of an arterial vessel with a large-bore catheter occurs in infants (check one) The catheter should be left in place The catheter may be nonsurgically removed 9. When unintended cannulation of an arterial vessel with a large bore catheter occurs in children (check one) The catheter should be left in place The catheter may be nonsurgically removed Strongly Agree Agree Equivocal Disagree Strongly Disagree 250 17.2 26.0 31.6* 17.2 8.0 248 46.0 40.3* 11.3 2.4 0.0 1.2 0.0 249 62.7* 30.9 5.2 243 7.0 14.0 52.2* 20.2 6.6 249 22.5 36.6* 35.3 4.8 0.8 249 38.6 35.3* 24.5 1.2 0.4 244 Percentage 54.9 45.1 249 Percentage 43.8 56.2 244 Percentage 30.0 70.0 * Number of SPA members who responded to each item. An asterisk beside a percentage score indicates the median response. † Younger than 44 gestational weeks. ‡ Younger than 2 yr. § 2–16 yr of age. I The complete wording of the response category is: The catheter should be left in place and a general surgeon, vascular surgeon, or interventional radiologist should be immediately consulted before deciding on whether to remove the catheter, either surgically or nonsurgically. # The complete wording of the response category is: The catheter may be nonsurgically removed without consulting a general surgeon, vascular surgeon, or interventional radiologist. 39 Practice Guidelines Table 5. Evidence Summary* Interventions Evidence Category1 I. Resource preparation Catheterization in environment that permits use of aseptic techniques Standardized equipment set An assistant A checklist or protocol II. Prevention of infectious complications Intravenous antibiotic prophylaxis Prophylactic intravenous antibiotics should not be administered routinely Prophylactic intravenous antibiotics should be administered to immunocompromised patients and high- risk neonates Aseptic techniques and barrier precautions: Maximal barrier vs. gloves and small drape only "Bundled" elements: handwashing, sterile full body drapes, sterile, gloves, caps, and masks Specific activities: Consultant Survey2 D ASA Member Survey2 SPA Member Survey2 Guideline Recommendation Strongly agree Strongly agree Should be performed Strongly agree Agree (trained) Strongly agree Strongly agree Agree (trained) Agree Should be available Should be used Should be used D administered Agree Agree Should not be routinely A24 case basis Agree Agree Administer on a case-by- D D D D D 100% agreement 87% agreement 100% agreement 100% agreement 100% agreement 100% agreement 96% agreement 74% agreement 88% agreement 100% agreement 95% agreement 98% agreement D infants and children Strongly agree Strongly agree D D B23 C25,6 B23 Hand washing Sterile full-body drape Sterile gown Sterile gloves Caps Masks covering both mouth and nose Skin preparation: Solutions containing chlorhexidine: Chlorhexidine with alcohol (patient age not specified) Antiseptic solutions containing chlorhexidine for: Neonates judgment and Institutional protocol Infants Children Solutions containing alcohol: Chlorhexidine without alcohol vs. povidone-iodine without alcohol Chlorhexidine with alcohol vs. Povidone-iodine with alcohol Skin preparation solutions with vs. without alcohol: Chlorhexidine D D D D Use Use Use Use Use Use Should be used for adults, Equivocal Agree Strongly agree Should be based on clinical Should be used Should be used C25,7 D D (continued) 40 SPECIAL ARTICLES Table 5. Continued Interventions Evidence Category1 Povidone-iodine A35/C28 Skin preparation solutions containing alcohol Catheters containing antimicrobial agents: Antibiotic-coated A15 catheters pts) C13/C25 Silver-impregnated catheters Chlorhexidine and silver sulfadiazine A15/B39/C13 coated catheters Selection of catheter insertion site: Internal jugular vs. subclavian C23,5/C33,5 subclavian site A35/C24 Subclavian vs. femoral femoral) Catheter fixation: Risk of catheter-related infections with suture, staple, tape Catheter insertion site dressings: Transparent bio-occlusive Chlorhexidine sponge dressings (patient age not specified) Chlorhexidineimpregnated transparent dressings for neonates Chlorhexidine sponge dressings For neonates judgment and institutional protocol For infants D D C23,5 contraindicated Consultant Survey2 ASA Member Survey2 Guideline Recommendation Use unless contraindicated Agree (selected Agree (selected pts) Agree (selected Agree (selected pts) pts) Should be used for selected patients No recommendation Should be used for selected patients Majority prefer Majority prefer internal jugular site Agree (avoid Agree (avoid femoral) Site selection should be based on clinical need to minimize risk of catheter- related infection Site selection should be based on clinical need. In adults, upper body site should be considered to minimize risk of infection Majority prefer Majority prefer suture suture Should be determined on a local or institutional basis Strongly agree Agree Strongly agree Agree Should be used May be used unless A310 judgment and institutional protocol Should be based on clinical Equivocal Agree For children Silver-impregnated transparent dressings Catheter maintenance: Duration of catheterization related to higher colonization/infection rates Duration of catheterization should be based on clinical need Specific time intervals between insertion site inspections Catheter change interval 3-days vs. 7-days Daily assessment of clinical need for continuing catheterization SPA Member Survey2 Agree C25 Should be based on clinical May be used, unless contraindicated May be used, unless contraindicated No recommendation B24,5 Strongly agree on clinical need Agree Duration should be based Strongly agree Clinical need for keeping D C25 Strongly agree catheter in place should be assessed daily (continued) 41 Practice Guidelines Table 5. Continued Consultant Survey2 ASA Member Survey2 Conduct daily catheter site inspections Strongly agree Strongly agree Change or remove catheter when infection is suspected Strongly agree Strongly agree Strongly agree (Suspected infection) Strongly agree (Suspected infection) Strongly agree Strongly agree Interventions When catheter-related infection is suspected, replace catheter using new insertion site vs. catheter change over a guidewire Promptly remove catheter when deemed no longer clinically necessary Aseptic techniques using an existing central venous catheter: Wipe port with an appropriate antiseptic before access Cap stopcocks or access ports when not in use Evidence Category1 C15 D Strongly agree Strongly agree should be wiped with an appropriate antiseptic before each access Strongly agree Strongly agree stopcocks or access ports should be capped when not in use Needleless catheter connectors/access ports vs. standard caps Agree Needleless catheter connectors/ports A211/C23 Agree (case-by (case-by case basis) vs. standard caps case III. Prevention of mechanical basis) trauma or injury Selection of catheter insertion site: C213,14,15,16/C317 Internal jugular vs. subclavian Subclavian vs. femoral A312 Preferred catheter Majority prefer internal Majority prefer insertion site jugular internal jugular Positioning the patient for needle insertion and catheter placement: Trendelenburg vs. normal supine SPA Member Survey2 Guideline Recommendation Catheter insertion site should be inspected daily for signs of infection Catheter should be changed or removed when Catheter insertion site infection is suspected When catheter-related infection is suspected, replacing the catheter using a new insertion site is preferred Promptly remove catheter when deemed no longer clinically necessary Catheter access ports Central venous catheter Needless catheter access ports may be used on a case-by-case basis Insertion site selection should be based on clinical need and practitioner judgment, experience and skill. In adults, selection of an upper body insertion site should be considered to minimize the risk of thromboembolic injury or trauma Strongly agree Strongly agree When clinically appropriate B218 and feasible, central venous access in the neck or chest should be performed with the patient in the Trendelenburg position (continued) 42 SPECIAL ARTICLES Table 5. Continued Interventions Evidence Category1 Needle insertion, wire and catheter placement: Selection of catheter size and type Large-bore catheters associated with unintentional arterial cannulation Modified Seldinger vs. Seldinger technique Limiting the number of insertion attempts Introducing two catheters in the same central vein Guidance of needle placement in elective situations: Static ultrasound for preprocedural vessel localization vs. landmark approach: Internal jugular vein access Consultant Survey2 ASA Member Survey2 D Agree clinical situation and the skill and experience of the (modified Seldinger) technique or a thin-wall needle method used to confirm that the wire resides in the D Agree judgment B220/C313,15 Agree Should be based on the operator; the decision to use a catheter-over-the- needle (Seldinger) technique should be based at least in part on the vein before a dilator or large-bore catheter is threaded Agree Should be based on clinical Strongly agree Agree (case-by(case-by-case) case) Agree (elective situations) Agree Femoral vein access Guideline Recommendation Strongly agree Strongly agree Should be based on the clinical situation and the skill and experience of the practitioner; selection of the smallest size catheter appropriate for the clinical situation should be considered Select the smallest size B319 catheter appropriate for the clinical situation A321/C222 Subclavian vein access SPA Member Survey2 (elective situations) C222 Equivocal (elective situations) D Agree (elective situations) Equivocal (elective situations) Equivocal (elective situations) Should be decided on a case-bycase basis Use May be used May be used Real-time ultrasound for guiding needle vs. landmark approach: Internal jugular vein access Subclavian vein access Femoral vein access A113,21,22,23/A224 (when available) A224/A313,15,16,23 Agree Equivocal (when available) Equivocal Equivocal (when (when available) available) A321,24 Equivocal (when Agree (when available) available) Use May be used May be used (continued) 43 Practice Guidelines Table 5. Continued Interventions Evidence Category1 Consultant Survey2 ASA Member Survey2 Verification of venous access: Confirm that catheter or thin-wall needle is in a vein SPA Member Survey2 Guideline Recommendation Strongly agree Strongly agree Confirm venous access after insertion of catheter that went over the needle or a thin-wall needle Ultrasound D An identified method An identified method Manometry B213 D An identified method Pressure waveform analysis Venous blood gas D An identified method D Should not be relied upon Absence of pulsatility, blood color to confirm venous access (based on Task Force opinion) Agree Equivocal When using the thin-wall Confirm venous residence of the wire needle technique, confirm venous residence of the wire after the wire is threaded 25 An identified method Ultrasound B2 B325 An identified method Transesophageal ultrasound Continuous electrocardiography D An identified method (based on Task Force opinion) Fluoroscopy D An identified method (based on Task Force opinion) Agree (when feasible) Agree (when Confirm if there is any uncertainty Confirm both the location of the feasible) that the catheter or wire resides in catheter or thin-wall needle and wire Verification of catheter the vein placement: Confirmation of final position of tip of catheter Confirm the final position of the catheter tip as soon as clinically appropriate (based on Task Force opinion) 26 Strongly agree Agree An identified method Fluoroscopy B2 Agree Agree An identified method Chest radiograph B226 A226 Continuous An identified method electrocardiography Unintended cannulation of an arterial vessel with a large bore catheter: Leave catheter in place (patient B327 Agree Agree For adults, the catheter age not specified) should be left in place and a general surgeon, a vascular surgeon, or an interventional radiologist should be immediately consulted For neonates Majority prefer Should be based on clinical judgment leaving in place Should be based on clinical judgment For infants Majority prefer nonsurgical removal (continued) 44 Table 5. Continued Interventions Evidence Category1 Consultant Survey2 ASA Member Survey2 For children SPA Member Survey2 Guideline Recommendation Majority prefer Should be based on clinical Nonsurgical removal judgment * Categories of evidence for literature: Category A: Supportive Literature. Randomized controlled trials report statistically significant (P < 0.01) differences between clinical interventions for a specified clinical outcome. Level 1: The literature contains multiple randomized controlled trials, and aggregated findings are supported by meta-analysis. † Level 2: The literature contains multiple randomized controlled trials, but the number of studies is insufficient to conduct a viable meta-analysis for the purpose of these Guidelines. Level 3: The literature contains a single randomized controlled trial. Category B: Suggestive Literature. Information from observational studies permits inference of beneficial or harmful relationships among clinical interventions and clinical outcomes. Level 1: The literature contains observational comparisons (e.g., cohort, case-control research designs) of clinical interventions or conditions and indicates statistically significant differences between clinical interventions for a specified clinical outcome. Level 2: The literature contains noncomparative observational studies with associative (e.g., relative risk, correlation) or descriptive statistics. Level 3: The literature contains case reports. Category C: Equivocal Literature. The literature cannot determine whether there are beneficial or harmful relationships among clinical interventions and clinical outcomes. Level 1: Meta-analysis did not find significant differences (P > 0.01) among groups or conditions. Level 2: The number of studies is insufficient to conduct meta-analysis, and (1) randomized controlled trials have not found significant differences among groups or conditions or (2) randomized controlled trials report inconsistent findings. Level 3: Observational studies report inconsistent findings or do not permit inference of beneficial or harmful relationships. Category D: Insufficient Evidence from Literature. The lack of scientific evidence in the literature is described by the following terms. Inadequate: The available literature cannot be used to assess relationships among clinical interventions and clinical outcomes. The literature either does not meet the criteria for content as defined in the “Focus” of the Guidelines or does not permit a clear interpretation of findings due to methodological concerns (e.g., confounding in study design or implementation). Silent: No identified studies address the specified relationships among interventions and outcomes. 1 All meta-analyses are conducted by the ASA methodology group. Meta-analyses from other sources are reviewed but not included as evidence in this document. 2 Survey data recorded on a 5-point scale: strongly agree - agree - equivocal - disagree - strongly disagree; reported findings represent the median survey response. 3 Catheter-related bloodstream infection. 4 Catheter-related infection and sepsis. 5 Catheter colonization. 6 Catheter-related septice- mia. 7 Catheter-related bacteremia. 8 Catheter-related infection and clinical signs of infection. 9 Anaphylactic shock. 10 Localized contact dermatitis. 11 Microbial contamination of stopcock entry ports. 12 Thrombotic complications. 13 Arterial puncture. 14 Deep vein thrombosis. 15 Hematoma. 16 Successful venipuncture. 17 Pneumothorax, hemothorax, or arrhythmia. 18 Diameter and cross sectional area of right internal jugular vein for patients older than 6 yr. 19 Severe injury (e.g., hemorrhage, hematoma, pseudoaneurysm, arteriovenous fistula, arterial dissection, neurologic injury including stroke, and severe or lethal airway obstruction) may occur. 20 Dysrhythmia. 21 First insertion attempt success rate. 22 Overall successful cannulation rate. 23 Access time. 24 Number of insertion attempts. 25 Confirmation of venous placement of wire. 26 Identifying the position of the catheter tip. 27 Fewer severe complications in adult patients. ated bloodstream infection rates decline after bundles and checklists. 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Ostendorf T, Meinhold A, Harter C, Salwender H, Egerer G, Geiss HK, Ho AD, Goldschmidt H: Chlorhexidine and silversulfadiazine coated central venous catheters in haematological patients–a double-blind, randomised, prospective, controlled trial. Support Care Cancer 2005; 13:993–1000 34. Rupp ME, Lisco SJ, Lipsett PA, Perl TM, Keating K, Civetta JM, Mermel LA, Lee D, Dellinger EP, Donahoe M, Giles D, Pfaller MA, Maki DG, Sherertz R: Effect of a second-generation venous catheter impregnated with chlorhexidine and silver sulfadiazine on central catheter-related infections: A randomized, controlled trial. Ann Intern Med 2005; 143: 570–80 35. Tennenberg S, Lieser M, McCurdy B, Boomer G, Howington E, Newman C, Wolf I: A prospective randomized trial of an antibiotic- and antiseptic-coated central venous catheter in the prevention of catheter-related infections. 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