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Neuraxial Anesthesia and the Use of Sterile Gowning
Neuraxial Anesthesia and the Use of Sterile Gowning HEIDI ALEMAN-ORTEGA, DNP, CRNA; REBECCA LEE, DNP, CRNA; LYDA SHAMBO, DNP, CRNA; EDWARD CZINN, MD
ABSTRACT Epidural or spinal anesthesiaerelated infections cause serious and devastating morbidity and mortality. The possible infectious complications of neuraxial anesthesia have become better understood in the past 10 years. We assessed information from published case series, studies, randomized controlled trials, and retrospective cohort studies to determine the rate of neuraxial infection and to evaluate iatrogenic causes of infection. The use of sterile gowning appears to be a factor associated with the decreased infection rates noted in some studies. A review of the literature demonstrated that personnel in interdisciplinary specialties use gowns for invasive procedures to prevent infection, and national and international multidisciplinary health care professionals appear to be increasing their use of sterile gowning to prevent infections. We undertook this literature review to explore the incidence of neuraxial infection, provide additional insight into multidisciplinary standards, and evaluate whether the use of sterile gowns while performing neuraxial anesthesia decreases infection rates. AORN J 105 (February 2017) 184-192. ª AORN, Inc, 2017. http://dx.doi.org/10.1016/j.aorn.2016. 12.004 Key words: epidural abscess, epidural infections, meningitis, sterile gowning, barrier techniques.
M
eticulous caution and vigilance are integral to the practice of anesthesia and to the prevention of anesthesia-related complications, particularly infections. Patients undergoing neuraxial anesthesia are at risk for infections that can lead to complications such as arachnoiditis, epidural abscess, meningitis, sepsis, cardiac arrest, or death.1-7 Infectious complications are known to cause serious and devastating morbidity and mortality; however, until recently, anesthesia professionals believed these complications to be rare in patients receiving neuraxial anesthesia.1-7 In the past 10 years, new studies have shown a higher incidence of infectious complications associated with neuraxial anesthesia than were previously reported.8,9 Sources of contamination include poor aseptic technique and bacterial migration along an epidural catheter track to deeper tissues.10,11 Other sources of infection include contaminated prep or local solutions, disconnection and subsequent
contamination of epidural catheters and catheter caps, and contamination from a patient’s own microbial flora resulting from substandard use of antiseptic prep solutions.4 Despite the increased experience and skill levels of anesthesia professionals who perform epidural anesthesia, Friedman et al11 found a nonsignificant correlation between infection and the practitioner’s aseptic technique. The standards of aseptic technique, particularly with respect to gowning while performing regional anesthesia, seem to be related to local practice standards.4,10,11 The objectives of this literature appraisal are to explore the incidence of neuraxial infection rates, provide additional insight into multidisciplinary standards, review international guidelines, evaluate whether the use of sterile gowns while performing neuraxial anesthesia decreases infection rates, and provide potential relevant information for future research. http://dx.doi.org/10.1016/j.aorn.2016.12.004 ª AORN, Inc, 2017
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POPULATION, INTERVENTION, COMPARISON, OUTCOME (PICO) FRAMEWORK We used the PICO12 framework to develop our research question. A PICO-type question is essential to the evidencebased decision-making process. The PICO question helps identify the population, the intervention, the comparison, and the outcome of the research. We set the inclusion criteria before performing our review of the literature. The following PICO question helped clearly define the studies’ eligibility criteria: In patients undergoing neuraxial anesthesia (population), does the use of sterile technique, including the use of a sterile gown during placement of neuraxial anesthesia (intervention), compare to aseptic technique without a sterile gown during placement of neuraxial anesthesia (comparison) to minimize risk of infection (outcome)?
LITERATURE REVIEW We conducted the literature review between September 2014 and September 2015. We restricted our search to Englishlanguage articles published in the three years before 2015. We used conventional methods to search for literature reviews, primary research, and expert opinion articles via electronic databases, including PubMed, MEDLINE, Ovid, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and the Journal of the American Medical Association. In addition, we performed a manual search of the reference lists from all pertinent articles and evaluated professional and national and international organization guidelines and standards pertaining to this subject. We set the search date inclusion criteria from September 2012 through September 2015. The search terms that we used were: epidural abscess, meningitis, epidural infections, and sterile gowning relating to the administration of anesthesia. The total number of published items we compiled was 5,119; of these, 5,101 were found via electronic search and 18 via reference lists. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) select reporting system for collecting research publications (Figure 1).13 During the first stage of the screening process, we eliminated more than 5,010 articles because they focused on epidural abscess, epidural infection, or meningitis independent of and unrelated to the administration of neuraxial anesthesia. We also excluded all other neuraxial complications that were not related to infections and all duplicate studies. The search terms epidural abscess, epidural infection, meningitis, and sterile gown produced the same studies as the search terms epidural abscess, epidural infection, meningitis, and maximum barrier in
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Neuraxial Anesthesia and Sterile Gowning
some search engines, but not all. We did not incorporate patient age as an exclusion criterion. Forty-nine articles remained and were advanced to secondary screening. During the secondary screening, we removed all articles and commentaries that did not offer initial research findings from the original study because of a low level of evidence. This search screening produced 33 articles that met the inclusion criteria. We then advanced all 33 studies and graded them according to the levels of evidence hierarchy described by Melnyk and Fineout-Overholt14 in 2011, which range from Level 1 (systematic reviews) to Level 7 (expert opinion) (Table 1). We retained seven guidelines from interdisciplinary, national, and international organizations (Table 2) for reference as secondary sources, which we used for an extrapolation of information but not for the critical appraisal of the literature. We then assessed 26 articles for quality using the Methodological Index for NonRandomized Studies (MINORS) score.15 Of these 26 articles, 10 involved either epidural colonization rates (Table 3) or epidural infection rates (Table 4). The articles used in this literature review had evidence levels ranging from Level 1 to 5. We did not include studies that lacked evidence-based quality ratings in the critical appraisal of the literature. We further assessed the quality of each study using the MINORS scoring,15 which is used to appraise quality measures that include
a clearly stated purpose, inclusion of consecutive patients, prospective collection of data, endpoints fitting to the purpose of the study, neutral or impartial valuation of the study endpoint, continuation period appropriate to the purpose of the study, loss of track or follow-up less than 5%, prospective design of the study size, an acceptable control group, control group and comparison group studied during the same period (no historical comparisons), baseline equality of groups, and acceptable statistical analyses. We scored each item as 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate). The global ideal score was 16 for noncomparative studies and 24 for comparative studies. We reviewed studies using the themes of epidural colonization rates, epidural infection rates, sterile-gowning guidelines, and anesthesia guidelines. We organized the studies from lowest to highest score based on the appraisal of both the quantitative design of the study (ie, level of evidence)14 and the MINORS qualitative measure of the research.15
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rate was found for the ungowned group; however, this difference was not found to be statistically significant.16 The study therefore emphasized the use of strict aseptic technique to minimize the potential for infectious complications in obstetric patients.16 The highest rate of catheter colonization was reported in a controlled study in which sterile gowns were not used. The researchers conducted the study on 205 patients with epidural catheters inserted for postoperative pain management. This study reported the epidural colonization rate to be 12.2%.10 In another RCT of 50 patients, Fasciolo et al17 reported a catheter colonization rate of 6% when practitioners used sterile gowns at the time of epidural catheter insertion. A prospective, observational study by Trojanowski and Janicki18 reported a colonization rate of 5.2% in 95 patients receiving indwelling epidural catheters for pain management when practitioners used sterile-gowning techniques. Epidural catheters were left in place for more than 24 hours postoperatively with no differences noted in catheterization time (P > .05).18 Mishra et al19 reported colonization rates of 5.7% in a prospective study of 466 immunocompromised cancer patients in which practitioners used sterile gowns and barrier techniques when inserting epidural catheters.
Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. Adapted from Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097, doi:10.1371/ journal.pmed.1000097. MINORS ¼ Methodological Index for Non-Randomized Studies.
Colonization Rates and Epidural Infection in Randomized Controlled Trials (RCTs) The colonization of an epidural catheter is one of many precursors to developing deeper tissue and epidural infections. Positive colonization is an essential antecedent to infection, and surface colonization may eventually channel into more profound infections.16 Most RCTs in our review studied the colonization rates of epidural catheters. In an RCT designed to investigate the result of sterile gowning on epidural colonization rates in obstetric patients, findings demonstrated a difference in colonization rates.16 A colonization rate of 7.6% was reported in the gowned group, and a 9.2% colonization 186 j AORN Journal
Epidural Infection Rates in Retrospective Studies Green and Paech4 retrospectively studied epidural catheterrelated infections in obstetric patients using the International Statistical Classification of Diseases coding to identify complications from spinal or epidural anesthesia. They reported that of the 9,482 obstetrical patients receiving epidural analgesia, 258 developed complications.4 Forty-nine of these patients developed epidural-related infections, four of which involved either an epidural or paraspinal abscess. Aseptic techniques in this study included the use of a sterile gown.2 In another retrospective study, Sethna et al20 concluded that epidural catheter infections occurred in 13 of 10,653 pediatric patients. Six of these infections occurred in patients with epidural catheters placed for an average of two days or longer (n ¼ 10,437). The researchers reported that practitioners inserted epidural catheters in the OR and adhered to strict aseptic techniques, but they did not wear sterile gowns. Practitioners administered antibiotics within 30 minutes of the surgical incision and administered them for 72 hours postoperatively or until the removal of the epidural catheter.20 The seven other epidural infections in this study occurred in
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Table 1. Levels of Evidence Ratings
Neuraxial Anesthesia and Sterile Gowning
1
Level 1
Evidence from a systematic review or metaanalysis of all relevant randomized controlled trials
Level 2
Evidence from well-designed randomized controlled trials
Level 3
Evidence from well-designed controlled trials without randomization
Level 4
Evidence from well-designed case-control and cohort studies
Level 5
Evidence from systematic reviews of descriptive and qualitative studies
Level 6
Evidence from single descriptive or qualitative studies
Level 7
Evidence from the opinion of authorities or reports of expert committees
Reference 1. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
patients who received epidural anesthesia for pain management (n ¼ 216). Notably, the infection rate was significantly higher when practitioners inserted epidural catheters for chronic pain management (3.2%). Prophylactic antibiotics were not administered to patients receiving epidural catheters for pain management.20 Of the retrospective studies we reviewed, Cameron et al9 reported the highest incidence of epidural infection rates. The authors reported on 8,210 nonobstetric patients receiving epidural analgesia during a 16-year span. Researchers reported the mean duration of catheter insertion as 2.8 days with a standard deviation of 1.3 days, and they found that the incidence of epidural site infections was 184 in 8,210 patients.9 Six of these patients were diagnosed with an epidural abscess (1:1,368).9 The researchers made no mention of sterile gown use during epidural insertions in this study.9 In another retrospective study,8 11 of 3,152 children developed an epidural-related infection. The researchers provided no evidence that either prophylactic antibiotics or sterile gowns were used during insertion of epidural catheters.8 The lowest reported rate of epidural infection originates from a retrospective study conducted in a private hospital in Turkey.21 Five anesthesiologists self-reported no infections in a select group of 34,109 patients.21 There is no evidence that sterile gowns were used during insertion of epidural catheters. This study had multiple limitations, including methods of patient selection, lack of blinding, and self-reporting.
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Overall, the literature demonstrates inconsistent epidural infection rates that vary depending on the hospital and country.4,9,10,16,19,21 Reasons cited for this variance include patient population, differences in clinical practice, duration of catheters in situ, and differences in sterile technique.4,8,9,16-21 The one prevailing, well-defined outcome is the risk of infection as a result of neuraxial anesthesia.
DISCUSSION To decrease the threat of infection related to neuraxial anesthesia, several interventions have been instituted; for example, in June 2007, the Healthcare Infection Control Practices Advisory Committee (HICPAC)2 recommended that all practitioners wear a mask when performing spinal procedures. This recommendation was the result of several instances of meningitis reported after myelography procedures. Despite these recommendations, HICPAC describes five subsequent instances of bacteriological meningitis after the administration of neuraxial anesthesia.2 Three of these were reported by the New York Department of Health in September 2008.2 In May 2009, practitioners reported two additional cases of meningitis to the Ohio Department of Health.2 All five patients were women who had received intrapartum spinal anesthesia. In each case, either the anesthesiologist performing the procedure or other personnel in the room did not wear a mask. Since 1994, AORN has recommended that all personnel performing sterile preps cover their arms with a long-sleeved cover jacket to prevent contamination of the sterile field.22 The long-sleeved jacket helps contain the skin squames (ie, a scale or flake from the skin) shed from the arms that may fall onto the surgical prep area, increasing the patient’s chance for a surgical site infection. This recommendation for nonscrubbed perioperative personnel has been, and continues to be, part of the AORN’s “Guideline for surgical attire.”22 In 2012, the Society of Interventional Radiology, AORN, the Association for Radiologic and Imaging Nursing, and the Society of Interventional Radiology Standards of Practice Committee developed a joint practice guideline for sterile technique; the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association endorsed the guideline.23 This guideline recommends the use of a sterile gown during invasive vascular and interventional procedures.23 A committee with expertise in the performance of interventional radiology procedures prepared the document and concluded that not using sterile gowns while performing RCTs may have exposed patients to unnecessary harm. AORN Journal j 187
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Table 2. Level 7 Interdisciplinary Guidelines for Sterile Gowning Professional Organization
Publication Year
Recommendation
The Association of Anaesthetists of Great Britain and Ireland (AAGBI)
2015
When central neural spaces are entered, complete sterile safety measures are required, including the use of a sterile gown.
Australian and New Zealand College of Anaesthetists (ANZCA)
2015
Maximum barrier precautionsdincluding complete hand hygiene; the donning of sterile gloves and gown, a hair cover, and mask; and the use of a large sterile drapedshould be used.
AORN
2014
All personnel performing sterile preparations should have their arms covered by a long-sleeved jacket to prevent contamination of the sterile field and thus to help decrease the occurrence of surgical site infection.
American Society of Health-System Pharmacists (ASHP)
2014
Gowns must be worn for preparation of sterile compounds to decrease contamination.
Deutsche Gesellschaft f€ ur An€ asthesiologie und Intensivmedizin (DGIA)
2015
A sterile gown should be worn for continuous epidural catheter procedures.
Israel Society of Anesthesiologist (ISA)
2015
Epidural or spinal anesthesia or analgesia should be performed under sterile conditions, including: hand hygiene with septol, and use of sterile gloves, cap, mask, and sterile gown. The assistant (eg, midwife) should wear a cap and mask.
Accordingly, the HICPAC Committee’s 2011 publication “Guidelines for the prevention of intravascular catheterrelated infections” strongly recommends strict adherence to sterile gowning for interventional radiology procedures and invasive vascular procedures.24 In 2014, the American Society of Health-System Pharmacists set guidelines that include gowning when compounding sterile preparations.25 These guidelines were developed after an outbreak of meningitis caused by fungal contamination of methylprednisolone used for neuraxial injections occurred.26 During this outbreak, the Centers for Disease Control and Prevention promptly initiated public health actions, notifying health care providers and patients, leading to rapid clinical assessments and initiation of antifungal therapy for infected patients.27 This prompt action dramatically reduced the predicted mortality rate and effects of this disease.26,27 As of October 23, 2013, there had been 751 cases of meningitis and 64 deaths reported by the Centers for Disease Control and Prevention, even with the prompt treatment of all patients and total recall of known infected lots of this compound.28
Sterile Technique and Rates of Contamination Several studies have demonstrated that gowning and gloving decrease health care worker clothing contamination. One study found that the use of gloves and gowns for all patient encounters in intensive care units correlated with a 70% 188 j AORN Journal
reduction in the acquisition of common pathogenic bacteria from the clothing of health care workers.29 In the Benefits of Universal Glove and Gown trial, a subgroup analysis of 20 intensive care units concluded that there was a reduction in the incidence of methicillin-resistant Staphylococcus aureus infection in units that used universal gowning and gloving.30 The use of sterile gowns and gloves is considered a best practice standard for the prevention of central lineeassociated bloodstream infection (CLABSI).31 In a retrospective study, CLABSI was more probable in patients in which a maximal sterile barrier was not used (P ¼ .03), whereas the use of a maximal sterile barrier was independently associated with a decreased rate of CLABSI.31 Researchers did not observe a correlation between the rates of CLABSI and the catheter type, insertion site, use or variety of hand hygiene, use of 2% chlorhexidine gluconate, or practitioner’s adherence to all recommendations in the CLABSI bundles. The largest contributing factor for preventing infection while inserting central lines was the use of maximal sterile technique, which included the use of sterile gowns. The use of sterile gowns while inserting central lines is now considered a standard of care.24
International Anesthesia Guidelines Gowning while performing regional anesthesia is considered standard practice in some parts of Europe.32-34 The
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Neuraxial Anesthesia and Sterile Gowning
Table 3. Epidural Catheter Colonization Rates Author
Publication Study Year Type
1,2
Location
Size (N)
Italy
50
Fasciolo et al3
2008
RCT
Mishra et al4
2014
Study
United Kingdom
Siddiqui et al5
2014
RCT
Canada
Trojanowski and Janicki6
2009
Study
United States
Yuan et al7
2008
RCT
Taiwan
Population
Colonization Rate
Gowned Versus Ungowned
LOE MINORS Score
Patients undergoing 6.0% postoperative pain management
Gowned
2
20
466
Cancer patients
5.70%
Gowned
3
18
214
Obstetric patients
7.6% gown Gowned versus 9.2% no gown ungowned
2
20
95
Patients undergoing 5.20% postoperative pain management
Gowned
3
20
205
Patients undergoing 12.2% postoperative pain management
Ungowned
2
18
LOE ¼ level of evidence; MINORS ¼ Methodological Index for Non-Randomized Studies; RCT ¼ randomized controlled trial. References 1. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:12. 2. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological Index for Non-Randomized Studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73(9):712-716. 3. Fasciolo A, Ambruosi C, Giacomazzi C, Hadjioannou P, Baldini C. Microbiological cultural test after prolonged peridural catheterization: report of 50 cases. Internet J Anesthesiol. 2007;15(2). http://ispub.com/IJA/15/2/13550. Accessed June 2, 2015. 4. Mishra S, Bhatnagar S, Srikanti M, Gupta D. Clinical implication of routine bacterial culture from epidural catheter tips in postoperative cancer patients: a prospective study. Anaesthesia. 2006;61(9):878-882. 5. Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014;39(6):520-524. 6. Trojanowski A, Janicki P. Bacterial contamination of epidural catheters used for perioperative analgesia. Internet J Anesthesiol. 2008;20(2). http://ispub.com/IJA/20/2/3469. Accessed June 2, 2015. 7. Yuan HB, Zuo Z, Yu KW, Lin WM, Lee HC, Chan KH. Bacterial colonization of epidural catheters used for short-term postoperative analgesia: microbiological examination and risk factor analysis. Anesthesiology. 2008;108(1):130-137.
Association of Anaesthetists of Great Britain and Ireland has developed infection control guidelines that institute maximal barrier provisions involving complete hand hygiene and the use of sterile gown and gloves, a head covering, a mask, and a large sterile drape.32 Invasive anesthetic procedures requiring this level of aseptic technique include the insertion of central venous catheters and the provision of spinal, epidural, and caudal anesthesia. Although the Association of Anaesthetists of Great Britain and Ireland is cognizant of the fact that many anesthesia care providers may not use this level of sterility for one-shot spinal or epidural anesthesia, they recommend that full aseptic safeguards be used when core neural spaces are entered. In Australia and New Zealand, maximum barrier precautions, including full body draping and the wearing of hat, face mask, and sterile gown and gloves, are mandated when a spinal or epidural block is being performed.33 They also mandate these
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precautions when regional anesthesia catheters are inserted and remain indwelling for postoperative pain management. In Germany, the use of a sterile gown for continuous-catheter procedures is also in effect.34 Noting the international changes, the American Society of Anesthesiologists assembled a team to analyze and create recommendations for aseptic practice for regional anesthesia in the United States.35 They concluded that the literature regarding the adequacy of aseptic strategies (eg, removal of jewelry; hand hygiene; wearing of caps, masks, sterile gloves) for reducing infectious complications during neuraxial procedures is lacking sufficient scientific evidence, stating that No identified studies address the specified relationships among interventions and outcomes. . The available literature cannot be used to assess relationships among clinical interventions and clinical outcomes. The literature either does not meet the AORN Journal j 189
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Table 4. Epidural Infection Rates Author
Publication Year
1,2
Study Type
Location
Size (N)
Population
Infection Rates (%)
Gowned versus Ungowned
LOE MINORS Score
Cameron et al3
2007
Retrospective Australia
8,210 Postoperative pain management, adult patients
0.022
Not mentioned
5
19
Green and Paech4
2010
Retrospective Australia and case series
9,482 Obstetric patients
0.005
Gowned
5
21
Katircioglu et al5
2008
Retrospective Turkey
0.000
Not mentioned
5
8
Sethna et al6
2010
Retrospective United 10,653 Children States
0.060
Gowned
5
20
Wong et al7
2013
Retrospective Canada
0.003
Ungowned
5
17
34,109 Obstetric and gynecologic patients
3,152 Children
LOE ¼ level of evidence; MINORS ¼ Methodological Index for Non-Randomized Studies. References 1. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing and Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:12. 2. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological Index for Non-Randomized Studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73(9):712-716. 3. Cameron CM, Scott DA, McDonald WM, Davies MJ. A review of neuraxial epidural morbidity: experience of more than 8,000 cases at a single teaching hospital. Anesthesiology. 2007;106(5):997-1002. 4. Green LK, Paech MJ. Obstetric epidural catheter-related infections at a major teaching hospital: a retrospective case series. Int J Obstet Anesth. 2010;19(1):38-43. 5. Katircioglu K, Hasegeli L, Ibrahimhakkioglu HF, Ulusoy B, Damar H. A retrospective review of 34,109 epidural anesthetics for obstetric and gynecologic procedures at a single private hospital in Turkey. Anesth Analg. 2008;107(5):1742-1745. 6. Sethna NF, Clendenin D, Athiraman U, Solodiuk J, Rodriguez DP, Zurakowski D. Incidence of epidural catheter-associated infections after continuous epidural analgesia in children. Anesthesiology. 2010;113(1):224-232. 7. Wong GK, Arab AA, Chew SC, Naser B, Crawford MW. Major complications related to epidural analgesia in children: a 15-year audit of 3,152 epidurals. Can J Anaesth. 2013;60(4):355-363.
criteria for content as defined in the Focus of the Advisory or does not permit a clear interpretation of findings due to methodologic concerns (i.e., confounding in study design or implementation).35(p2-3)
SUMMARY
warrants a proactive and preemptive practice to reduce patient harm. Therefore, the use of sterile gowns while performing neuraxial anesthesia should be considered for inclusion in clinical practice guidelines. Future research should focus on infection rates in institutions and countries that use sterile gowning as a standard of care. Using retrospective and prospective studies to compare colonization and infection rates before and after the institution of sterile gowning may provide valuable recommendations for maintaining sterile technique for neuraxial anesthesia and enhanced patient safety.
Despite international trends, the use of sterile gowns while administering neuraxial anesthesia remains controversial in the United States. Much of the controversy stems from the fact that no large RCTs have been performed to support or refute the idea that sterile gowning affects these infection rates. Barriers to such studies are, in part, related to the large sample population required to support study outcomes. Nonetheless, the risk of infection when performing neuraxial anesthesia is a potential adverse outcome that
Editor’s notes: PubMed is a registered trademark of the US National Library of Medicine, Bethesda, MD. CINAHL, Cumulative Index to Nursing and Allied Health Literature, is a registered trademark of EBSCO Industries, Birmingham, AL. MEDLINE is a registered trademark of the US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD. Ovid is a registered trademark of Ovid Technologies, New York, NY.
Although the use of sterile gowns when administering neuraxial anesthesia is not currently a standard in the United States, many experts are calling for their use in conjunction with sterile gloves, a hat, and a mask.36-38
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References 1. Barnwell R, Ball V. Iatrogenic bacterial meningitis: an unmasked threat. CJEM. 2012;14(4):259-262. 2. Centers for Disease Control and Prevention. Bacterial meningitis after intrapartum spinal anesthesiadNew York and Ohio, 20082009. MMWR Morb Mortal Wkly Rep. 2010;59(3):65-69. 3. Bussink M, Gramke H, van Kleef M, Marcus M. Bacterial meningitis ten days after spinal anesthesia. Reg Anesth Pain Med. 2005;30(2):210-211. 4. Green LK, Paech MJ. Obstetric epidural catheter-related infections at a major teaching hospital: a retrospective case series. Int J Obstet Anesth. 2010;19(1):38-43. 5. Grewal S, Hocking G, Wildsmith JA. Epidural abscesses. Br J Anaesth. 2006;96(3):292-302. 6. Gritsenko K, Marcello D, Liguori GA, Jules-Elysee K, Memtsoudis SG. Meningitis or epidural abscesses after neuraxial block for removal of infected hip or knee prostheses. Br J Anaesth. 2012;108(3):485-490. 7. Baer ET. Post-dural puncture bacterial meningitis. Anesthesiology. 2006;105(2):381-393. 8. Wong GK, Arab AA, Chew SC, Naser B, Crawford MW. Major complications related to epidural analgesia in children: a 15-year audit of 3,152 epidurals. Can J Anaesth. 2013;60(4):355-363. 9. Cameron CM, Scott DA, McDonald WM, Davies MJ. A review of neuraxial epidural morbidity: experience of more than 8,000 cases at a single teaching hospital. Anesthesiology. 2007;106(5):997-1002. 10. Yuan HB, Zuo Z, Yu KW, Lin WM, Lee HC, Chan KH. Bacterial colonization of epidural catheters used for short-term postoperative analgesia: microbiological examination and risk factor analysis. Anesthesiology. 2008;108(1):130-137. 11. Friedman Z, Siddiqui N, Katznelson R, Devito I, Davies S. Experience is not enough: repeated breaches in epidural anesthesia aseptic technique by novice operators despite improved skill. Anesthesiology. 2008;108(5):914-920. 12. Cooke A, Smith D, Booth A. Beyond PICO: the SPIDER tool for qualitative evidence synthesis. Qual Health Res. 2012;22(10): 1435-1443. 13. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and metaanalyses: the PRISMA statement. PLoS Med. 2009;6(7): e1000097. doi:10.1371/journal.pmed.1000097. 14. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011. 15. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological Index for Non-Randomized Studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73(9):712-716. 16. Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014;39(6):520-524. 17. Fasciolo A, Ambruosi C, Giacomazzi C, Hadjioannou P, Baldini C. Microbiological cultural test after prolonged peridural catheterization: report of 50 cases. Internet J Anesthesiol. 2007;15(2). http://ispub.com/IJA/15/2/13550. Accessed June 2, 2015.
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Neuraxial Anesthesia and Sterile Gowning 18. Trojanowski A, Janicki P. Bacterial contamination of epidural catheters used for perioperative analgesia. Internet J Anesthesiol. 2008; 20(2). http://ispub.com/IJA/20/2/3469. Accessed June 2, 2015. 19. Mishra S, Bhatnagar S, Srikanti M, Gupta D. Clinical implication of routine bacterial culture from epidural catheter tips in postoperative cancer patients: a prospective study. Anaesthesia. 2006; 61(9):878-882. 20. Sethna NF, Clendenin D, Athiraman U, Solodiuk J, Rodriguez DP, Zurakowski D. Incidence of epidural catheter-associated infections after continuous epidural analgesia in children. Anesthesiology. 2010;113(1):224-232. 21. Katircioglu K, Hasegeli L, Ibrahimhakkioglu HF, Ulusoy B, Damar H. A retrospective review of 34,109 epidural anesthetics for obstetric and gynecologic procedures at a single private hospital in Turkey. Anesth Analg. 2008;107(5):1742-1745. 22. Guideline for surgical attire. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2017:105-128. 23. Chan D, Downing D, Keough CE, et al. Joint practice guideline for sterile technique during vascular and interventional radiology procedures: from the Society of Interventional Radiology, Association of periOperative Registered Nurses, and Association for Radiologic and Imaging Nursing, for the Society of Interventional Radiology Standards of Practice Committee, and endorsed by the Cardiovascular Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association. J Vasc Interv Radiol. 2012;23(12):1603-1612. 24. O’Grady NP, Alexander M, Burns LA, et al; Healthcare Infection Control Practices Advisory Committee (HICPAC). 2011 guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. http://www.cdc.gov/hi cpac/bsi/bsi-guidelines-2011.html. Accessed October 12, 2016. 25. American Society of Health-System Pharmacists. ASHP guidelines on compounding sterile preparations. Am J Health Syst Pharm. 2014;71(2):145-166. 26. Smith RM, Derado G, Wise M, et al. Estimated deaths and illnesses averted during fungal meningitis outbreak associated with contaminated steroid injections, United States, 2012-2013. Emerg Infect Dis. 2015;21(6):933-940. 27. Bell BP, Khabbaz RF. Responding to the outbreak of invasive fungal infections: the value of public health to Americans. JAMA. 2013;309(9):883-884. 28. Healthcare-associated infections (HAI). Multistate outbreak of fungal meningitis and other infectionsdcase count. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/outbreaks/ meningitis-map-large.html. Updated October 30, 2015. Accessed September 19, 2016. 29. Williams C, McGraw P, Schneck EE, et al. Impact of universal gowning and gloving on health care worker clothing contamination. Infect Control Hosp Epidemiol. 2015;36(4):431-437. 30. Morgan DJ, Pineles L, Shardell M, et al. Effect of chlorhexidine bathing and other infection control practices on the Benefits of Universal Glove and Gown (BUGG) trial: a subgroup analysis. Infect Control Hosp Epidemiol. 2015;36(6):734-737. 31. Tang HJ, Lin HL, Lin YH, Leung PO, Chuang YC, Lai CC. The impact of central line insertion bundle on central line-associated bloodstream infection. BMC Infect Dis. July 1, 2014;14:356.
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Aleman-Ortega et al 32. The Association of Anaesthetists of Great Britain and Ireland. AAGBI safety guideline: infection control in anaesthesia. Anaesthesia. 2008;63(9):1027-1036. https://www.aagbi.org/sites/default/files/ infection_control_08.pdf. Accessed September 19, 2016. 33. Guidelines on infection control in anaesthesia. Australian and New Zealand College of Anaesthetists (ANZCA). http://www.anzca.edu .au/resources/professional-documents/pdfs/ps28-2015-guidelines -on-infection-control-in-anaesthesia.pdf. Published June 2015. Accessed September 19, 2016. 34. Training curriculum infection management in intensive care (IMI) [in German]. Deutsche Gesellschaft f€ur An€asthesiologie und Intensivmedizin. http://www.dgai.de. Accessed September 19, 2016. 35. American Society of Anesthesiologists Task Force on Infectious Complications Associated with Neuraxial Techniques. Practice advisory for the prevention, diagnosis, and management of infectious complications associated with neuraxial techniques: a report by the American Society of Anesthesiologists Task Force on Infectious Complications Associated with Neuraxial Techniques. Anesthesiology. 2010; 112(3):530-545. 36. Ioscovich A, Davidson EM, Orbach-Zinger S, et al. Performance of aseptic technique during neuraxial analgesia for labor before and after the publication of international guidelines on aseptic technique. Isr J Health Policy Res. 2014;3(1):9. 37. Biddle C. Semmelweis revisited: hand hygiene and nosocomial disease transmission in the anesthesia workstation. AANA J. 2009;77(3):229-237. 38. Hepner DL. Gloved and maskeddwill gowns be next? The role of asepsis during neuraxial instrumentation. Anesthesiology. 2006; 105(2):241-243.
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Heidi Aleman-Ortega, DNP, CRNA, is the chief CRNA in the Department of Anesthesiology at Broward Health Medical Center, Fort Lauderdale, FL. Dr AlemanOrtega has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Rebecca Lee, DNP, CRNA, is the program director and assistant professor of Anesthesiology at the Barry University College of Nursing and Health Sciences, Hollywood, FL. Dr Lee has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Lyda Shambo, DNP, CRNA, is the assistant program director of the Graduate Program in Nurse Anesthesia at the Columbia University School of Nursing, New York, NY. Dr Shambo has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Edward Czinn, MD, is the medical director of the Department of Anesthesiology at Broward Health Medical Center, Fort Lauderdale, FL; and clinical assistant professor of Surgery at the Herbert Wertheim College of Medicine, Florida International University, Miami. Dr Czinn has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
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ABSTRACT Epidural or spinal anesthesiaerelated infections cause serious and devastating morbidity and mortality. The possible infectious complications of neuraxial anesthesia have become better understood in the past 10 years. We assessed information from published case series, studies, randomized controlled trials, and retrospective cohort studies to determine the rate of neuraxial infection and to evaluate iatrogenic causes of infection. The use of sterile gowning appears to be a factor associated with the decreased infection rates noted in some studies. A review of the literature demonstrated that personnel in interdisciplinary specialties use gowns for invasive procedures to prevent infection, and national and international multidisciplinary health care professionals appear to be increasing their use of sterile gowning to prevent infections. We undertook this literature review to explore the incidence of neuraxial infection, provide additional insight into multidisciplinary standards, and evaluate whether the use of sterile gowns while performing neuraxial anesthesia decreases infection rates. AORN J 105 (February 2017) 184-192. ª AORN, Inc, 2017. http://dx.doi.org/10.1016/j.aorn.2016. 12.004 Key words: epidural abscess, epidural infections, meningitis, sterile gowning, barrier techniques.
M
eticulous caution and vigilance are integral to the practice of anesthesia and to the prevention of anesthesia-related complications, particularly infections. Patients undergoing neuraxial anesthesia are at risk for infections that can lead to complications such as arachnoiditis, epidural abscess, meningitis, sepsis, cardiac arrest, or death.1-7 Infectious complications are known to cause serious and devastating morbidity and mortality; however, until recently, anesthesia professionals believed these complications to be rare in patients receiving neuraxial anesthesia.1-7 In the past 10 years, new studies have shown a higher incidence of infectious complications associated with neuraxial anesthesia than were previously reported.8,9 Sources of contamination include poor aseptic technique and bacterial migration along an epidural catheter track to deeper tissues.10,11 Other sources of infection include contaminated prep or local solutions, disconnection and subsequent
contamination of epidural catheters and catheter caps, and contamination from a patient’s own microbial flora resulting from substandard use of antiseptic prep solutions.4 Despite the increased experience and skill levels of anesthesia professionals who perform epidural anesthesia, Friedman et al11 found a nonsignificant correlation between infection and the practitioner’s aseptic technique. The standards of aseptic technique, particularly with respect to gowning while performing regional anesthesia, seem to be related to local practice standards.4,10,11 The objectives of this literature appraisal are to explore the incidence of neuraxial infection rates, provide additional insight into multidisciplinary standards, review international guidelines, evaluate whether the use of sterile gowns while performing neuraxial anesthesia decreases infection rates, and provide potential relevant information for future research. http://dx.doi.org/10.1016/j.aorn.2016.12.004 ª AORN, Inc, 2017
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POPULATION, INTERVENTION, COMPARISON, OUTCOME (PICO) FRAMEWORK We used the PICO12 framework to develop our research question. A PICO-type question is essential to the evidencebased decision-making process. The PICO question helps identify the population, the intervention, the comparison, and the outcome of the research. We set the inclusion criteria before performing our review of the literature. The following PICO question helped clearly define the studies’ eligibility criteria: In patients undergoing neuraxial anesthesia (population), does the use of sterile technique, including the use of a sterile gown during placement of neuraxial anesthesia (intervention), compare to aseptic technique without a sterile gown during placement of neuraxial anesthesia (comparison) to minimize risk of infection (outcome)?
LITERATURE REVIEW We conducted the literature review between September 2014 and September 2015. We restricted our search to Englishlanguage articles published in the three years before 2015. We used conventional methods to search for literature reviews, primary research, and expert opinion articles via electronic databases, including PubMed, MEDLINE, Ovid, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and the Journal of the American Medical Association. In addition, we performed a manual search of the reference lists from all pertinent articles and evaluated professional and national and international organization guidelines and standards pertaining to this subject. We set the search date inclusion criteria from September 2012 through September 2015. The search terms that we used were: epidural abscess, meningitis, epidural infections, and sterile gowning relating to the administration of anesthesia. The total number of published items we compiled was 5,119; of these, 5,101 were found via electronic search and 18 via reference lists. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) select reporting system for collecting research publications (Figure 1).13 During the first stage of the screening process, we eliminated more than 5,010 articles because they focused on epidural abscess, epidural infection, or meningitis independent of and unrelated to the administration of neuraxial anesthesia. We also excluded all other neuraxial complications that were not related to infections and all duplicate studies. The search terms epidural abscess, epidural infection, meningitis, and sterile gown produced the same studies as the search terms epidural abscess, epidural infection, meningitis, and maximum barrier in
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some search engines, but not all. We did not incorporate patient age as an exclusion criterion. Forty-nine articles remained and were advanced to secondary screening. During the secondary screening, we removed all articles and commentaries that did not offer initial research findings from the original study because of a low level of evidence. This search screening produced 33 articles that met the inclusion criteria. We then advanced all 33 studies and graded them according to the levels of evidence hierarchy described by Melnyk and Fineout-Overholt14 in 2011, which range from Level 1 (systematic reviews) to Level 7 (expert opinion) (Table 1). We retained seven guidelines from interdisciplinary, national, and international organizations (Table 2) for reference as secondary sources, which we used for an extrapolation of information but not for the critical appraisal of the literature. We then assessed 26 articles for quality using the Methodological Index for NonRandomized Studies (MINORS) score.15 Of these 26 articles, 10 involved either epidural colonization rates (Table 3) or epidural infection rates (Table 4). The articles used in this literature review had evidence levels ranging from Level 1 to 5. We did not include studies that lacked evidence-based quality ratings in the critical appraisal of the literature. We further assessed the quality of each study using the MINORS scoring,15 which is used to appraise quality measures that include
a clearly stated purpose, inclusion of consecutive patients, prospective collection of data, endpoints fitting to the purpose of the study, neutral or impartial valuation of the study endpoint, continuation period appropriate to the purpose of the study, loss of track or follow-up less than 5%, prospective design of the study size, an acceptable control group, control group and comparison group studied during the same period (no historical comparisons), baseline equality of groups, and acceptable statistical analyses. We scored each item as 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate). The global ideal score was 16 for noncomparative studies and 24 for comparative studies. We reviewed studies using the themes of epidural colonization rates, epidural infection rates, sterile-gowning guidelines, and anesthesia guidelines. We organized the studies from lowest to highest score based on the appraisal of both the quantitative design of the study (ie, level of evidence)14 and the MINORS qualitative measure of the research.15
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rate was found for the ungowned group; however, this difference was not found to be statistically significant.16 The study therefore emphasized the use of strict aseptic technique to minimize the potential for infectious complications in obstetric patients.16 The highest rate of catheter colonization was reported in a controlled study in which sterile gowns were not used. The researchers conducted the study on 205 patients with epidural catheters inserted for postoperative pain management. This study reported the epidural colonization rate to be 12.2%.10 In another RCT of 50 patients, Fasciolo et al17 reported a catheter colonization rate of 6% when practitioners used sterile gowns at the time of epidural catheter insertion. A prospective, observational study by Trojanowski and Janicki18 reported a colonization rate of 5.2% in 95 patients receiving indwelling epidural catheters for pain management when practitioners used sterile-gowning techniques. Epidural catheters were left in place for more than 24 hours postoperatively with no differences noted in catheterization time (P > .05).18 Mishra et al19 reported colonization rates of 5.7% in a prospective study of 466 immunocompromised cancer patients in which practitioners used sterile gowns and barrier techniques when inserting epidural catheters.
Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. Adapted from Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097, doi:10.1371/ journal.pmed.1000097. MINORS ¼ Methodological Index for Non-Randomized Studies.
Colonization Rates and Epidural Infection in Randomized Controlled Trials (RCTs) The colonization of an epidural catheter is one of many precursors to developing deeper tissue and epidural infections. Positive colonization is an essential antecedent to infection, and surface colonization may eventually channel into more profound infections.16 Most RCTs in our review studied the colonization rates of epidural catheters. In an RCT designed to investigate the result of sterile gowning on epidural colonization rates in obstetric patients, findings demonstrated a difference in colonization rates.16 A colonization rate of 7.6% was reported in the gowned group, and a 9.2% colonization 186 j AORN Journal
Epidural Infection Rates in Retrospective Studies Green and Paech4 retrospectively studied epidural catheterrelated infections in obstetric patients using the International Statistical Classification of Diseases coding to identify complications from spinal or epidural anesthesia. They reported that of the 9,482 obstetrical patients receiving epidural analgesia, 258 developed complications.4 Forty-nine of these patients developed epidural-related infections, four of which involved either an epidural or paraspinal abscess. Aseptic techniques in this study included the use of a sterile gown.2 In another retrospective study, Sethna et al20 concluded that epidural catheter infections occurred in 13 of 10,653 pediatric patients. Six of these infections occurred in patients with epidural catheters placed for an average of two days or longer (n ¼ 10,437). The researchers reported that practitioners inserted epidural catheters in the OR and adhered to strict aseptic techniques, but they did not wear sterile gowns. Practitioners administered antibiotics within 30 minutes of the surgical incision and administered them for 72 hours postoperatively or until the removal of the epidural catheter.20 The seven other epidural infections in this study occurred in
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Table 1. Levels of Evidence Ratings
Neuraxial Anesthesia and Sterile Gowning
1
Level 1
Evidence from a systematic review or metaanalysis of all relevant randomized controlled trials
Level 2
Evidence from well-designed randomized controlled trials
Level 3
Evidence from well-designed controlled trials without randomization
Level 4
Evidence from well-designed case-control and cohort studies
Level 5
Evidence from systematic reviews of descriptive and qualitative studies
Level 6
Evidence from single descriptive or qualitative studies
Level 7
Evidence from the opinion of authorities or reports of expert committees
Reference 1. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
patients who received epidural anesthesia for pain management (n ¼ 216). Notably, the infection rate was significantly higher when practitioners inserted epidural catheters for chronic pain management (3.2%). Prophylactic antibiotics were not administered to patients receiving epidural catheters for pain management.20 Of the retrospective studies we reviewed, Cameron et al9 reported the highest incidence of epidural infection rates. The authors reported on 8,210 nonobstetric patients receiving epidural analgesia during a 16-year span. Researchers reported the mean duration of catheter insertion as 2.8 days with a standard deviation of 1.3 days, and they found that the incidence of epidural site infections was 184 in 8,210 patients.9 Six of these patients were diagnosed with an epidural abscess (1:1,368).9 The researchers made no mention of sterile gown use during epidural insertions in this study.9 In another retrospective study,8 11 of 3,152 children developed an epidural-related infection. The researchers provided no evidence that either prophylactic antibiotics or sterile gowns were used during insertion of epidural catheters.8 The lowest reported rate of epidural infection originates from a retrospective study conducted in a private hospital in Turkey.21 Five anesthesiologists self-reported no infections in a select group of 34,109 patients.21 There is no evidence that sterile gowns were used during insertion of epidural catheters. This study had multiple limitations, including methods of patient selection, lack of blinding, and self-reporting.
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Overall, the literature demonstrates inconsistent epidural infection rates that vary depending on the hospital and country.4,9,10,16,19,21 Reasons cited for this variance include patient population, differences in clinical practice, duration of catheters in situ, and differences in sterile technique.4,8,9,16-21 The one prevailing, well-defined outcome is the risk of infection as a result of neuraxial anesthesia.
DISCUSSION To decrease the threat of infection related to neuraxial anesthesia, several interventions have been instituted; for example, in June 2007, the Healthcare Infection Control Practices Advisory Committee (HICPAC)2 recommended that all practitioners wear a mask when performing spinal procedures. This recommendation was the result of several instances of meningitis reported after myelography procedures. Despite these recommendations, HICPAC describes five subsequent instances of bacteriological meningitis after the administration of neuraxial anesthesia.2 Three of these were reported by the New York Department of Health in September 2008.2 In May 2009, practitioners reported two additional cases of meningitis to the Ohio Department of Health.2 All five patients were women who had received intrapartum spinal anesthesia. In each case, either the anesthesiologist performing the procedure or other personnel in the room did not wear a mask. Since 1994, AORN has recommended that all personnel performing sterile preps cover their arms with a long-sleeved cover jacket to prevent contamination of the sterile field.22 The long-sleeved jacket helps contain the skin squames (ie, a scale or flake from the skin) shed from the arms that may fall onto the surgical prep area, increasing the patient’s chance for a surgical site infection. This recommendation for nonscrubbed perioperative personnel has been, and continues to be, part of the AORN’s “Guideline for surgical attire.”22 In 2012, the Society of Interventional Radiology, AORN, the Association for Radiologic and Imaging Nursing, and the Society of Interventional Radiology Standards of Practice Committee developed a joint practice guideline for sterile technique; the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association endorsed the guideline.23 This guideline recommends the use of a sterile gown during invasive vascular and interventional procedures.23 A committee with expertise in the performance of interventional radiology procedures prepared the document and concluded that not using sterile gowns while performing RCTs may have exposed patients to unnecessary harm. AORN Journal j 187
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Table 2. Level 7 Interdisciplinary Guidelines for Sterile Gowning Professional Organization
Publication Year
Recommendation
The Association of Anaesthetists of Great Britain and Ireland (AAGBI)
2015
When central neural spaces are entered, complete sterile safety measures are required, including the use of a sterile gown.
Australian and New Zealand College of Anaesthetists (ANZCA)
2015
Maximum barrier precautionsdincluding complete hand hygiene; the donning of sterile gloves and gown, a hair cover, and mask; and the use of a large sterile drapedshould be used.
AORN
2014
All personnel performing sterile preparations should have their arms covered by a long-sleeved jacket to prevent contamination of the sterile field and thus to help decrease the occurrence of surgical site infection.
American Society of Health-System Pharmacists (ASHP)
2014
Gowns must be worn for preparation of sterile compounds to decrease contamination.
Deutsche Gesellschaft f€ ur An€ asthesiologie und Intensivmedizin (DGIA)
2015
A sterile gown should be worn for continuous epidural catheter procedures.
Israel Society of Anesthesiologist (ISA)
2015
Epidural or spinal anesthesia or analgesia should be performed under sterile conditions, including: hand hygiene with septol, and use of sterile gloves, cap, mask, and sterile gown. The assistant (eg, midwife) should wear a cap and mask.
Accordingly, the HICPAC Committee’s 2011 publication “Guidelines for the prevention of intravascular catheterrelated infections” strongly recommends strict adherence to sterile gowning for interventional radiology procedures and invasive vascular procedures.24 In 2014, the American Society of Health-System Pharmacists set guidelines that include gowning when compounding sterile preparations.25 These guidelines were developed after an outbreak of meningitis caused by fungal contamination of methylprednisolone used for neuraxial injections occurred.26 During this outbreak, the Centers for Disease Control and Prevention promptly initiated public health actions, notifying health care providers and patients, leading to rapid clinical assessments and initiation of antifungal therapy for infected patients.27 This prompt action dramatically reduced the predicted mortality rate and effects of this disease.26,27 As of October 23, 2013, there had been 751 cases of meningitis and 64 deaths reported by the Centers for Disease Control and Prevention, even with the prompt treatment of all patients and total recall of known infected lots of this compound.28
Sterile Technique and Rates of Contamination Several studies have demonstrated that gowning and gloving decrease health care worker clothing contamination. One study found that the use of gloves and gowns for all patient encounters in intensive care units correlated with a 70% 188 j AORN Journal
reduction in the acquisition of common pathogenic bacteria from the clothing of health care workers.29 In the Benefits of Universal Glove and Gown trial, a subgroup analysis of 20 intensive care units concluded that there was a reduction in the incidence of methicillin-resistant Staphylococcus aureus infection in units that used universal gowning and gloving.30 The use of sterile gowns and gloves is considered a best practice standard for the prevention of central lineeassociated bloodstream infection (CLABSI).31 In a retrospective study, CLABSI was more probable in patients in which a maximal sterile barrier was not used (P ¼ .03), whereas the use of a maximal sterile barrier was independently associated with a decreased rate of CLABSI.31 Researchers did not observe a correlation between the rates of CLABSI and the catheter type, insertion site, use or variety of hand hygiene, use of 2% chlorhexidine gluconate, or practitioner’s adherence to all recommendations in the CLABSI bundles. The largest contributing factor for preventing infection while inserting central lines was the use of maximal sterile technique, which included the use of sterile gowns. The use of sterile gowns while inserting central lines is now considered a standard of care.24
International Anesthesia Guidelines Gowning while performing regional anesthesia is considered standard practice in some parts of Europe.32-34 The
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Table 3. Epidural Catheter Colonization Rates Author
Publication Study Year Type
1,2
Location
Size (N)
Italy
50
Fasciolo et al3
2008
RCT
Mishra et al4
2014
Study
United Kingdom
Siddiqui et al5
2014
RCT
Canada
Trojanowski and Janicki6
2009
Study
United States
Yuan et al7
2008
RCT
Taiwan
Population
Colonization Rate
Gowned Versus Ungowned
LOE MINORS Score
Patients undergoing 6.0% postoperative pain management
Gowned
2
20
466
Cancer patients
5.70%
Gowned
3
18
214
Obstetric patients
7.6% gown Gowned versus 9.2% no gown ungowned
2
20
95
Patients undergoing 5.20% postoperative pain management
Gowned
3
20
205
Patients undergoing 12.2% postoperative pain management
Ungowned
2
18
LOE ¼ level of evidence; MINORS ¼ Methodological Index for Non-Randomized Studies; RCT ¼ randomized controlled trial. References 1. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing & Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:12. 2. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological Index for Non-Randomized Studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73(9):712-716. 3. Fasciolo A, Ambruosi C, Giacomazzi C, Hadjioannou P, Baldini C. Microbiological cultural test after prolonged peridural catheterization: report of 50 cases. Internet J Anesthesiol. 2007;15(2). http://ispub.com/IJA/15/2/13550. Accessed June 2, 2015. 4. Mishra S, Bhatnagar S, Srikanti M, Gupta D. Clinical implication of routine bacterial culture from epidural catheter tips in postoperative cancer patients: a prospective study. Anaesthesia. 2006;61(9):878-882. 5. Siddiqui NT, Davies S, McGeer A, Carvalho JC, Friedman Z. The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial. Reg Anesth Pain Med. 2014;39(6):520-524. 6. Trojanowski A, Janicki P. Bacterial contamination of epidural catheters used for perioperative analgesia. Internet J Anesthesiol. 2008;20(2). http://ispub.com/IJA/20/2/3469. Accessed June 2, 2015. 7. Yuan HB, Zuo Z, Yu KW, Lin WM, Lee HC, Chan KH. Bacterial colonization of epidural catheters used for short-term postoperative analgesia: microbiological examination and risk factor analysis. Anesthesiology. 2008;108(1):130-137.
Association of Anaesthetists of Great Britain and Ireland has developed infection control guidelines that institute maximal barrier provisions involving complete hand hygiene and the use of sterile gown and gloves, a head covering, a mask, and a large sterile drape.32 Invasive anesthetic procedures requiring this level of aseptic technique include the insertion of central venous catheters and the provision of spinal, epidural, and caudal anesthesia. Although the Association of Anaesthetists of Great Britain and Ireland is cognizant of the fact that many anesthesia care providers may not use this level of sterility for one-shot spinal or epidural anesthesia, they recommend that full aseptic safeguards be used when core neural spaces are entered. In Australia and New Zealand, maximum barrier precautions, including full body draping and the wearing of hat, face mask, and sterile gown and gloves, are mandated when a spinal or epidural block is being performed.33 They also mandate these
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precautions when regional anesthesia catheters are inserted and remain indwelling for postoperative pain management. In Germany, the use of a sterile gown for continuous-catheter procedures is also in effect.34 Noting the international changes, the American Society of Anesthesiologists assembled a team to analyze and create recommendations for aseptic practice for regional anesthesia in the United States.35 They concluded that the literature regarding the adequacy of aseptic strategies (eg, removal of jewelry; hand hygiene; wearing of caps, masks, sterile gloves) for reducing infectious complications during neuraxial procedures is lacking sufficient scientific evidence, stating that No identified studies address the specified relationships among interventions and outcomes. . The available literature cannot be used to assess relationships among clinical interventions and clinical outcomes. The literature either does not meet the AORN Journal j 189
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Table 4. Epidural Infection Rates Author
Publication Year
1,2
Study Type
Location
Size (N)
Population
Infection Rates (%)
Gowned versus Ungowned
LOE MINORS Score
Cameron et al3
2007
Retrospective Australia
8,210 Postoperative pain management, adult patients
0.022
Not mentioned
5
19
Green and Paech4
2010
Retrospective Australia and case series
9,482 Obstetric patients
0.005
Gowned
5
21
Katircioglu et al5
2008
Retrospective Turkey
0.000
Not mentioned
5
8
Sethna et al6
2010
Retrospective United 10,653 Children States
0.060
Gowned
5
20
Wong et al7
2013
Retrospective Canada
0.003
Ungowned
5
17
34,109 Obstetric and gynecologic patients
3,152 Children
LOE ¼ level of evidence; MINORS ¼ Methodological Index for Non-Randomized Studies. References 1. Melnyk BM, Fineout-Overholt E. Evidence-Based Practice in Nursing and Healthcare: A Guide to Best Practice. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:12. 2. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological Index for Non-Randomized Studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73(9):712-716. 3. Cameron CM, Scott DA, McDonald WM, Davies MJ. A review of neuraxial epidural morbidity: experience of more than 8,000 cases at a single teaching hospital. Anesthesiology. 2007;106(5):997-1002. 4. Green LK, Paech MJ. Obstetric epidural catheter-related infections at a major teaching hospital: a retrospective case series. Int J Obstet Anesth. 2010;19(1):38-43. 5. Katircioglu K, Hasegeli L, Ibrahimhakkioglu HF, Ulusoy B, Damar H. A retrospective review of 34,109 epidural anesthetics for obstetric and gynecologic procedures at a single private hospital in Turkey. Anesth Analg. 2008;107(5):1742-1745. 6. Sethna NF, Clendenin D, Athiraman U, Solodiuk J, Rodriguez DP, Zurakowski D. Incidence of epidural catheter-associated infections after continuous epidural analgesia in children. Anesthesiology. 2010;113(1):224-232. 7. Wong GK, Arab AA, Chew SC, Naser B, Crawford MW. Major complications related to epidural analgesia in children: a 15-year audit of 3,152 epidurals. Can J Anaesth. 2013;60(4):355-363.
criteria for content as defined in the Focus of the Advisory or does not permit a clear interpretation of findings due to methodologic concerns (i.e., confounding in study design or implementation).35(p2-3)
SUMMARY
warrants a proactive and preemptive practice to reduce patient harm. Therefore, the use of sterile gowns while performing neuraxial anesthesia should be considered for inclusion in clinical practice guidelines. Future research should focus on infection rates in institutions and countries that use sterile gowning as a standard of care. Using retrospective and prospective studies to compare colonization and infection rates before and after the institution of sterile gowning may provide valuable recommendations for maintaining sterile technique for neuraxial anesthesia and enhanced patient safety.
Despite international trends, the use of sterile gowns while administering neuraxial anesthesia remains controversial in the United States. Much of the controversy stems from the fact that no large RCTs have been performed to support or refute the idea that sterile gowning affects these infection rates. Barriers to such studies are, in part, related to the large sample population required to support study outcomes. Nonetheless, the risk of infection when performing neuraxial anesthesia is a potential adverse outcome that
Editor’s notes: PubMed is a registered trademark of the US National Library of Medicine, Bethesda, MD. CINAHL, Cumulative Index to Nursing and Allied Health Literature, is a registered trademark of EBSCO Industries, Birmingham, AL. MEDLINE is a registered trademark of the US National Library of Medicine’s Medical Literature Analysis and Retrieval System, Bethesda, MD. Ovid is a registered trademark of Ovid Technologies, New York, NY.
Although the use of sterile gowns when administering neuraxial anesthesia is not currently a standard in the United States, many experts are calling for their use in conjunction with sterile gloves, a hat, and a mask.36-38
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Heidi Aleman-Ortega, DNP, CRNA, is the chief CRNA in the Department of Anesthesiology at Broward Health Medical Center, Fort Lauderdale, FL. Dr AlemanOrtega has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Rebecca Lee, DNP, CRNA, is the program director and assistant professor of Anesthesiology at the Barry University College of Nursing and Health Sciences, Hollywood, FL. Dr Lee has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Lyda Shambo, DNP, CRNA, is the assistant program director of the Graduate Program in Nurse Anesthesia at the Columbia University School of Nursing, New York, NY. Dr Shambo has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
Edward Czinn, MD, is the medical director of the Department of Anesthesiology at Broward Health Medical Center, Fort Lauderdale, FL; and clinical assistant professor of Surgery at the Herbert Wertheim College of Medicine, Florida International University, Miami. Dr Czinn has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
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