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NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION Practice Guide for Anesthetic Management of the Parturient Undergoing External Cephalic Version (ECV) Joseph P. McVicker East Carolina University College of Nursing 1 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 2 Approval Practice Guide for Anesthetic Management of the Parturient Undergoing External Cephalic Version (ECV) This DNP Scholarly Project by Joseph P. McVicker is recommended for approval. Signature on File________________________________________________________________ Robin Webb Corbett, PhD, FNP-C, RNC Date Committee Chair Signature on File________________________________________________________________ Michelle Taylor Skipper, DNP, FNP-BC Date Signature on File________________________________________________________________ Steven Banks, MD, FACOG Date LCDR, MC, USN Community Member Signature on File________________________________________________________________ Michelle Skipper, DNP, FNP-BC Date DNP Program Director NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 3 Abstract Despite the World Health Organization’s recommendation that cesarean delivery (CD) rates not exceed 15%, one in three women in the United States have a CD. This is a 50% increase since the mid 1990’s. The Term Breech Trial resulted in a perceived prohibition of elective vaginal delivery (VD) for breech presentation (BP). BP of the fetus occurs in 3-4% of all pregnancies, accounts for 6-8% of primary CD, and 87-98% of all BPs result in CD. “…The most important determinant of the overall cesarean rate is the primary cesarean rate” (Branch & Silver, 2012, p.946). The American College of Obstetricians and Gynecologists (ACOG) recommends offering external cephalic version (ECV) to all parturients that are determined to be acceptable candidates. ECV presents a statistically safe alternative to CD for fetal BP at term when VD is desired (Collaris & Oei, 2004). Fear of pain frequently results in refusal of ECV and pain is a frequent reason for termination of ECV attempts. In addition to alleviating pain, central neuraxial blockade (CNB) reduces abdominal muscle tone leading to an increased success rate of ECV. Naval Hospital Camp Lejeune (NHCL) has no standard practice for involving anesthesia in the pre-procedural counseling and management of ECV candidates. The goal of this project is the development of an agency clinical practice protocol based on best evidence to guide the care of patients undergoing ECV at NHCL. Following an extensive literature review, an agency clinical practice protocol is developed and formally presented to stakeholders for future implementation based on an interprofessional care model. NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 4 Acknowledgments I would like to thank my wife, Susan McVicker, for her love and support throughout this academic journey. I am grateful for the support of my academic committee including my chair, Dr. Robin Webb-Corbett, Dr. Tracey Bell, and my community member, Dr. Steven Banks. Additionally, I express my gratitude to the Commanding Officer of Naval Hospital Camp Lejeune for allowing me to conduct my scholarly project within his organization. The support of Naval Hospital Camp Lejeune’s departments of anesthesia, obstetrics, family medicine, nursing and professional education was without a doubt a major motivating and supportive factor in the completion of this project. Last, but not least, I would like to thank Mrs. Kerry Sewell of the Laupus Library for her patience and research strategy assistance. NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 5 TABLE OF CONTENTS CHAPTER I. II. INTRODUCTION………………………………………………. RESEARCH BASED EVIDENCE……………………………… Breech Presentation and Cesarean Delivery Statistical Data……. Cesarean Delivery Concerns…………………………………….. External Cephalic Version to Avoid Cesarean Delivery………... Anesthesia and External Cephalic Version……………………… Risks of Anesthesia in Obstetric Patients……………………….. Cost and Efficacy……………………………………………….. THEORETICAL MODEL……………………………………… METHODOLOGY……………………………………………… The Need for a Practice Protocol……………………………….. Search Strategy………………………………………………….. Resources and Project Cost Analysis…………………………… RESULTS……………………………………………………….. DISCUSSION…………………………………………………… SUMMARY……………………………………………………... 6 7 7 7 7 10 12 14 15 19 19 19 20 21 23 24 REFERENCES…………………………………………………………………. 25 APPENDICES………………………………………………………………….. 33 III. IV. V. VI. VII. NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 6 Practice Guide for Anesthetic Management of the Parturient Undergoing External Cephalic Version (ECV) In the United States, the majority of women diagnosed with fetal breech presentation (BP) at term deliver their babies by Cesarean delivery (CD). This is due to documented higher maternal and fetal morbidity and mortality associated with vaginal breech delivery. The option of external cephalic version (ECV) or manually turning the fetus to a cephalic or vertex presentation is an alternative for women desiring vaginal delivery (VD). Frequently women who were candidates for ECV have refused it due to fear of pain, and pain has been the most common reason for terminating ECV attempts. The purpose of this project was to establish an agency clinical practice protocol for anesthesia consultation and management of parturients who are candidates for ECV at Naval Hospital Camp Lejeune (NHCL). NHCL is a community hospital with a high volume, full service obstetric practice that provides care for active duty military personnel and their families. With approximately 2,000 deliveries including 272 CDs in 2015, NHCL is the third most productive obstetric service in Navy Medicine. In the same year, there were 35 ECV procedures performed at NHCL with only twelve of these procedures performed in conjunction with central neuraxial blockade (CNB). What is not known is the number of patients eligible for ECV, the number of patients who refuse the procedure, and whether consultation with anesthesia would increase procedural acceptance and effect a further decease in the frequency of CD at NHCL. The absence of a local or professional organizational clinical practice guideline (CPG) provided an opportunity to apply an evidence-based process improvement initiative for the anesthetic management of this patient population. The process improvement project was presented to the department heads of anesthesia and obstetrics. Following their approval, the Director of Surgical NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 7 Services was briefed and a letter of support was received from the Commanding Officer of NHCL (see Appendix A). Research Based Evidence Breech Presentation and Cesarean Delivery Statistical Data Despite the World Health Organization’s recommendation that CD rates not exceed 15% (Wang, Tan, Kanagalingam, & Tan, 2013), one in three women in the United States have a CD (Martin, Hamilton, Ventura, Osterman, & Mathews, 2013). This is a 50% rate increase since the mid 1990’s (Branch & Silver, 2012). If the current trend in primary and secondary CD continues, 56.2% of all deliveries in the U.S. by 2020 will be by CD (Solheim et al., 2011). BP of the fetus occurs in 3-4% of all pregnancies at term (Bogner et al., 2014; Truijens, van der Zalm, Pop, & Kuppens, 2014; Vlemmix et al., 2013). BP accounts for 6-8% of all primary CD and 87-98% of BPs at term result in elective CD (Tan, Macario, Carvalho, Druzin, & El-Sayed, 2010; Weiniger et al., 2010; Weiniger, 2013). Women who have had a prior CD due to BP have a 91% CD recidivism rate resulting in as much as a 20% contribution to the overall elective CD rate (Weiniger, 2013). Preston and Jee (2013) propose a reduction in the rate of CD in Canada of up to 14% utilizing ECV to avoid elective, primary CD. According to Branch & Silver, “…the most important determinant of the overall cesarean rate is the primary cesarean rate” (2012, p. 946). Of note, the presence of a uterine scar from a previous CD does not preclude ECV to facilitate a trial of labor and the possibility of VD (Abenhaim, Varin, & Boucher, 2009; Burgos et al., 2014). Cesarean Delivery Concerns The Term Breech Trial, an international, multicenter, randomized trial conducted by Hannah et al. (2000) revealed significant maternal and neonatal morbidity associated with NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 8 elective VDs with breech presentation. Subsequently, elective VDs for breech presentation (BP) at term fell into disfavor and CD became the preferred mode of delivery for this patient population (Weiniger, 2013). Despite the preference for CD when BP is diagnosed at term, CD is considered major abdominal surgery and presents significant immediate and delayed risks to the mother (see Table 1), (Silver et al., 2006). This concern for maternal morbidity was reaffirmed in a study evaluating adjacent organ injury, including bladder and bowel, in repetitive CDs (Ozcan et al., 2015). There is also a subsequent increase risk for malpresentation in future pregnancies for women who have had a prior CD (Hehir et al., 2012). Table 1 Maternal Morbidity of Women Who Had Cesarean Deliveries Without Labor The preference to opt for CD in order to avoid neonatal complications associated with vaginal breech delivery was challenged and arguments were made that when strict criteria were met, planned vaginal breech delivery was safer than CD (Goffinet et al., 2006). This assertion for the safety of vaginal breech delivery was later discounted by a 2016 meta-analysis that reported perinatal morbidity and mortality at two- to five- fold greater in vaginal breech NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 9 deliveries when compared to CD (Berhan & Haileamlak, 2016). Fetal and perinatal risks associated with breech presentation and delivery at term are presented in Table 2. There is short term risk of neonatal asphyxia, scalp lacerations, respiratory morbidities, immunologic effects, altered gastrointestinal flora, negative hematologic effects, as well as negative hemodynamic effects due to alteration in norepinephrine production, with additional evidence to support an association of CD with asthma, food allergy, and atopy (Gregory, Jackson, Korst, & Fridman, 2012). The aggregate maternal, fetal, and perinatal risks support cephalic vaginal delivery in contrast to CD. Table 2 Fetal and Perinatal Risks Associated with Breech Presentation and Delivery at Term Complication Incidence Intrapartum fetal death Increased 16-fold Perinatal mortality 1.30% Intrapartum asphyxia Increased 3.8-fold Cord prolapse Increased 5-20-fold, 1.3% Birth trauma Increased 13-fold, 1.4% Dystocia, difficulty delivering head 4.6-8.8% Spinal cord injury with extended head 21% Major anomalies 6-18% Prematurity 16-33% Hyperextension of the head 5% Fetal heart rate abnormalities 15.20% From “Malpresentations and Shoulder Dystocia,” by S. M. Seeds, J. W. Seeds, 2012. In S.G. Gabbe, J. R. Niebyl, et al, (Eds), Obstetrics: Normal and problem pregnancies (pp. 388-414) Philadelphia: Elsevier/Sanders. Adapted with permission. External Cephalic Version to Avoid Cesarean Delivery Many techniques have been attempted to induce the spontaneous repositioning of the fetus to a cephalic presentation. Maternal knee chest positioning, relaxation techniques, spinal vibroacoustic stimulation, warmed saline amniotic infusions, acupuncture, burning of an herb called moxibustion near the skin, and a positioning technique called Indian Version have all been NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 10 attempted strategies to facilitate cephalic version (Bolaji & Alabi-Isama, 2009). In the absence of conflicting co-morbidities, pregnant women, with singleton pregnancies and a diagnosis of BP at term are candidates for ECV (ACOG, 2015). Elective ECV presents a safe, viable alternative to CD for women who present with fetal BP at term and desire to attempt VD (Bogner et al., 2014; Lim et al., 2014; Rosman et al., 2014, Vlemmix et al., 2013). It is beyond the scope of this project to discuss and determine patient eligibility or candidacy for ECV. CD remains the primary delivery mode for term BP (Aaronson & Goodman, 2014). Success rate for ECV without anesthesia varies from 20% to 60% with most reports in the 50% range (Bogner et al., 2014; Kok, Van Der Steeg, Mol, Opmeer, & Van Der Post, 2008; Lim et al., 2014; Weiniger, 2013). The rate of CD following successful ECV is decreased to 21% (de Hundt, Velzel, de Groot, Mol, & Kok, 2014). Despite ACOG’s recommendation that ECV should be offered to all acceptable candidates, only up to 70% of women undergo procedural attempts at ECV (Rosman et al., 2014). Fear of pain is expressed 25% of the time and is the most common reason for refusal of ECV (Ciliacus et al., 2014; Rijnders, Offerhaus, van Dommelen, Wiegers, & Buitendijk, 2010; Truijens et al., 2014; Vlemmix et al., 2013). Pain is cited as a frequent reason for termination of ECV attempts. This is supported by an eight fold greater incidence of termination of ECV attempts due to pain for patients without anesthesia as compared to women with an anesthetic (Goetzinger, Harper, Tuuli, Macones, & Colditz, 2011). Anesthesia and External Cephalic Version General anesthesia was initially used to facilitate ECV but has since been abandoned in favor of CNB due to a 1% incidence of fetal mortality associated with general anesthesia (Bolaji & Alabi-Isama, 2009). CNB is a general term that includes epidural, spinal and combined spinal-epidural techniques. These techniques involve the placement of a needle into the vertebral NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 11 canal to facilitate the injection of local anesthetics and/or opiates into the epidural space or spinal fluid (Bolaji & Alabi-Isama, 2009). Anesthesia with CNB anesthesia remains the only technique with grade A evidence to support its use to increase the success rate of fetal version and decrease the incidence of CD (Bolaji & Alabi-Isama, 2009). All CNB techniques have been shown to decrease pain and increase the success rates of ECV when anesthetic as opposed to analgesic doses of local anesthetic are delivered (Lavoie & Guay, 2010; Sultan & Carvalho, 2011). Furthermore, CNB reduces abdominal muscle tone and guarding contributing to the increased success rate of successful ECV attempts (Weiniger, 2013). Spinal anesthesia was shown to be effective in increasing the success rate of ECV in nulliparous women and increasing the VD rate (Weiniger et al., 2007). Although patients report increased satisfaction and decreased pain scores with intravenous and CNB analgesia, neither of these approaches consistently increases the success rate of ECV. In contrast, CNB using anesthetic dosing of local anesthetics did increase the success rate of ECV (Birnbach et al., 2001; Khaw et al., 2015; Sullivan et al., 2009). The efficacy of CNB anesthesia to facilitate ECV is supported in Table 3. Table 3 Efficacy of Central Neuraxial Block (CNB) Anesthesia, CNB Analgesia, and No Intervention for Facilitation External Cephalic Version (ECV) Success Study/Year Country Design ECV Success ECV Success ECV Success Favor ECV Rate w/ CNB Rate w/ CNB Rate w/ No w/CNB Anesthesia Analgesia Intervention Anesthesia Khaw/2015 Hong Kong RCT 83% (52/63) N/A 64% (40/63) Yes Weiniger/ 2013 Israel/ USA LR 68% (104/153) 45% (44/97) 38% (96/255) Yes Goetzinger/2012 USA SR & MA 60% (151/253) N/A 38% (96/255) Yes Sultan/2011* USA SR 69% (107/156) 45% (44/97) 38% (96/255) Yes Lavoie/2010 Canada MA 64% (80/125) 44% (94/214) 35% (121/342) Yes Weiniger/2010 Israel RCT 87% (27/31) N/A 58% (19/33) Yes Yoshida/ 2010 Japan RC 79% (41/52) N/A 56% (19/34) Yes Bolaji/ 2009 UK SR & MA 51% (174/339) N/A 35% (103/295) Yes Sullivan/2009 USA RCT N/A 47% (23/48) 31% (15/48) N/A Macarthur/2004 Canada MA 50% (119/238) N/A 34% (82/242) Yes Birnbach/2001 USA PSNR N/A 80% (16/20) 33% (5/15) N/A Note. RCT-Randomized Controlled Trial, LR- Literature Review, SR-Systematic Review, MA-Meta-Analysis, RC-Retrospective Cohort Study, PSNR-Prospective Study Not Randomized. *Data limited to include only Randomized Controlled Studies of Neuraxial Blockade for ECV. NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 12 Risks of Anesthesia in Obstetric Patients CNB in the obstetric population is not without risk. Appropriate patient evaluation to determine eligibility and risk stratification for the procedure is required. The more common risks and complications of CNB include maternal hypotension, as frequent as 90%, which must be taken seriously as it directly impacts placental perfusion, but this is routinely treated with intravenous fluid and vasopressor medications (Stamer & Wulf, 2001). Post dural puncture headache occurs in 2.5% of patients who receive spinal anesthesia and two thirds of patients who have accidental dural puncture with larger epidural needles (Stamer & Wulf, 2001). The rate of unintentional dural puncture is reported as high as 3.6% in facilities performing less than 300 epidurals and as low as 0.19% in facilities performing at least 1,000 epidurals annually (Stamer & Wulf, 2001). Of those obstetrical patients receiving CNB only 0.2% require subsequent invasive treatment with epidural blood patch for post dural puncture headache (Yamasato, Kaneshiro, & Salcedo, 2015). Bacteremia, systemic bacterial infection, is preclusive of CNB due to the risk of meningitis and epidural abscess with frequencies reported as high as 1:3,000 to 1:50,000. These rates are inclusive of developing and third world countries as well as immunocompromised patients who are at higher risk for infectious complications (Moen & Irestedt, 2008). In further discussion of morbidity, Moen and Irestedt (2008) report that western, developed nations have significantly lower rates of infectious complications with CNB. Spinal cord trauma is rare and an understanding of anatomical variation of spinal cord anatomy and proper selection of injection site all but obviates this complication (Moen & Irestedt, 2008). It is postulated that the lack of protective pain reflexes or biofeedback due to CNB may allow for greater pressure to be applied to the abdomen and uterus during ECV and potentially increase the risk of placental abruption or uterine rupture (Bolaji & Alabi-Isama, 2009; O’Brien NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 13 & Adashi, 2014). However, when failed ECV attempts without CNB were repeated with the addition of spinal anesthesia, success rates improved and substantially reduced force was needed in the subsequent, successful ECV efforts with no increased incidence of maternal or fetal morbidity (Suen et al., 2012). Success rates for ECV in the 36-37 gestational age fetuses increased from 56% to 79% with CNB with a resulting decrease in CD rate from 50% to 33% for this population (Yoshida et al., 2010). Repeating ECV attempts with CNB following an initial failed attempt without CNB was advocated in an earlier prospective study (Cherayil, Feinberg, Robinson, & Tsen, 2002). ACOG does not advocate ECV prior to 37 weeks (ACOG, 2016). Despite the evidence that CNB improves the success rate for ECV at 37 weeks without increased morbidity, it is common practice in the U.S., as well as at NHCL, to attempt ECV at 37 weeks without anesthesia and if unsuccessful, reattempt ECV at 39 weeks with CNB in place so that immediate CD may be performed if ECV is again unsuccessful (Caughey & El-Sayed, 2010). If ECV is successful at 39 weeks, labor is induced and the epidural catheter placed for the ECV is used for labor analgesia. When choosing to delay reattempts at ECV to 39 after a failed attempt without anesthesia at 37 weeks, the increase in fetal size at the later date may negatively impact the likelihood of successful ECV (Caughey & El-Sayed, 2010). Additionally, onset of spontaneous labor or rupture of the amniotic membranes when waiting to 39 weeks may also decrease the likelihood of success or outright preclude ECV attempts (Bolaji & Alabi-Isama, 2009). There are concerns that ECV at 37 weeks would result in a significantly high rate of reversion to breech presentation, however, this rate is only 1-2% after 37 weeks (Collaris & Oei, 2004). The overall return to BP or reversion rate is reported to be 3-10% and includes patients receiving ECV at 36 weeks gestation (Tan et al, 2010). NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 14 Cost and Efficacy Any procedure must be evaluated not only for clinical efficacy but also procedural cost. The mean cost for ECV with CNB and VD is approximately $7,500 with CNB adding only $134 to the total cost. As reflected in Table 4, the cost for CD can exceed $9000 (Carvalho, Tan, Macario, El-Sayed, & Sultan, 2013). Table 4 Mean Costs (in 2010 US dollars) of External Cephalic Version (ECV) With and Without Neuraxial Anesthesia (CNB), Vaginal (VD), and Cesarean Delivery (CD) Hospital Cost OB & Nursing Svce. & Supplies Anesthesia Svce. & Supplies Mother’s time* Totals ECV $798 $174 $115 $1087 ECV w/CNB $798 $174 VD $3966 $1746 Elective CD $6291 $1954 Emergent CD $6291 $1971 $134 $218 $251 $535 $115 $1221 $345 $6275 $460 $8956 $575 $9372 Note. * Cost of mother’s time was itemized for each procedure expected duration/expected length of stay. Adapted from “A cost analysis of neuraxial anesthesia to facilitate external cephalic version for breech fetal presentation,” by Carvalho et al. 2013, Anesthesia and Analgesia, 117(1), 155-159. Copyright 2013 by International Anesthesia Research Society. The estimate for the cost CD does not include care for the neonate, which is usually greater following CD. CNB does increase the cost of the individual ECV procedure by approximately 12% but accounts for only 3% of the total delivery costs (Carvalho et al., 2013). Increasing the success rates of ECV and decreasing the rate of CD is cost effective in both the short and long term (Carvalho et al., 2013). The Carvalho et al. review includes the costs of anesthetic complications in their calculations (2013). Reports concerning costs must take the country of origin into account as CD rates and fixed costs including personnel vary widely (O'Brien & Adashi, 2014). Revenue generation, insurance reimbursements, and consumable supplies also have significant impacts on the cost analysis (Weiniger, Spencer, Weiss, Ginsberg, & Ezra, 2014). Future or delayed costs should also be considered. It is postulated that if 17 CDs can be avoided for every 100 ECV’s attempted, there would be a potential reduction of 10,000 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 15 CDs in the U.S. annually (Yamasato et al., 2015). Table 5 represents a more aggressive reduction of 29,508 CDs by performing ECV with CNB amounting to an annual cost savings of $37,588,351 (Niu et al., 2016). Table 5 Comparison of outcomes and costs for performing external cephalic version (ECV) with or without spinal anesthesia in a cohort of 126,000 nulliparous women with breech presentation Maternal deaths Cesarean Deliveries Successful ECVs Cost (in $100,000s) QALY (In 1000s) ECV w/Spinal 2 68,619 81,739 1,342 3,412 ECV w/o Spinal 2 98,127 39,705 1,379 3,409 Difference 0 29,508 42,034 38 3 From “External Cephalic Version with or without spinal anesthesia: a cost-effectiveness analysis,” by B. Niu et al. 2016, American Journal of Obstetrics and Gynecology, 214(1), S206. Copyright 2016 by Elsevier, Inc. Niu et al. did not identify the annual costs for CD in their report (2016). Additional savings will be realized in the subsequent CDs that will be avoided due to prevention of the primary CD (Yamasato et al., 2015). There is iatrogenic and incidental morbidity and mortality associated with CD (see Tables 1&2). These complications significantly increase the cost of healthcare. This author has not seen these additional expenses considered in any cost analysis in his review of the literature. When addressing cost from a societal or community health perspective, quality adjusted life years (QALY) are a significant consideration. ECV followed by VD resulted in a favorable calculation of $7,900/QALY (Tan et al., 2010). This is much lower than the $50,000/QALY threshold established to determine the favorability of an intervention (Tan et al., 2010). Theoretical Model Consistent with the doctor of nursing practice focus on translational research, process models present stages or steps to facilitate the translation of research into practice. The Iowa Model Revised: Evidence-Based Practice to Promote Excellence in Health Care (The Iowa NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 16 Model) is an action model (The Iowa Model Collaborative, 2015). The model’s 2015 version uses interdisciplinary verbiage favoring its use in health care applications. The streamlined flow chart of the model is depicted in Figure 1. Figure 1. The Iowa Model Revised: Evidence-Based Practice to Promote Excellence in Health Care. Used/Reprinted with permission from the University of Iowa Hospitals and Clinics. Copyright 2015. For permission to use or reproduce the model, please contact the University of Iowa Hospitals and Clinics at (319)384-9098. NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION The application of the framework to this project development is presented (see Figure 2). Figure 2. Iowa Model Outline on left. Parallel project application on right. 17 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 18 The first step of the process calls for identifying triggering issues or opportunities. For the purposes of this project the relatively recent increase in patients receiving ECV at NHCL with inconsistencies in consultation for anesthetic intervention by obstetricians and a variety of anesthetic management techniques comprised what the IOWA model describes a clinical trigger. Further inquiry revealed new preliminary evidence in the literature that found the variability in practice was inconsistent with the evidence. This led to the next step in the process map, stating the question. Is there evidence to support the development of a practice guide or protocol for the anesthetic management of ECV patients? Additionally, can the department of anesthesia effect a change in practice to improve the success rate of ECV and thereby decrease the rate of CD at NHCL? The formation of a team is the next step in the process. The core team for this project includes the author and academic committee. However, the NHCL department chairs of anesthesia and obstetrics as well as the director of surgical services who expressed interest and provided support for the endeavor are considered team members. Assembly, appraisal, and synthesis of the body of knowledge comprise the next phase in the Iowa Model (The Iowa Model Collaborative, 2015). The literature, with rare exception, reflects an overall consensus that the addition of CNB to ECV results in superior patient outcomes increasing success rates of ECV and decreasing the incidence of CD without increasing costs. In fact, there is overall savings in both the short-term and long-term prediction models (Carvalho et al., 2013). More importantly than cost, the maternal, fetal, and perinatal risks of CD are avoided. Following design and piloting the intervention, the Iowa Model continues with integrating and sustaining the practice change. It is at this phase that this project will end and leave post implementation evaluation for future study. The determination of appropriateness of the change to practice and subsequent integration and sustainment will be the NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 19 end outcome of the post implementation evaluation. Dissemination of the results is the final step in the process. This allows for feedback to those involved and contribution to the broader community promoting evidence-based practice (The Iowa Model Collaborative, 2015). Methodology The Need for a Practice Protocol ACOG, The American Society of Anesthesiologists, and The American Association of Nurse Anesthetists do not have published clinical practice guidelines for anesthesia involvement or management of parturients undergoing ECVs. Currently, NHCL does not have a standard practice or guideline for involvement of anesthesia as part of pre-procedural counseling and anesthetic management of ECV candidates. Search Strategy This project was reviewed and found to be outside the jurisdiction of the East Carolina University, University & Medical Center Institutional Review Board, as it does not meet the current federal descriptions of human subject research (see Appendix B). An extensive literature review of PubMed, OVID, and the Cochrane Database of Systematic Reviews was conducted. The search was limited to title and abstract restricting results to 2001 or later to focus on current evidence. Seminal publications were individually searched. The search terms included fetal version, external cephalic version, ECV, anesthesia, cesarean section, and costs. All articles published in peer-reviewed journals were eligible for inclusion. The author evaluated the results of this search and reviewed the title and abstract of all search results. Extraneous reports were excluded if not germane to the current subject. After eliminating duplicates, all remaining articles were obtained in full and evaluated. The author, based on subject matter and relationship to the current project, determined further exclusion. Manual review of remaining journal NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 20 reference pages was completed and additional articles were evaluated for inclusion. The search strategy flow sheet is presented (see Figure 3). PubMed: Fetal, Version, Anesthesia 39 results 18 excluded PubMed: Anesthesia, Cesarean Section, Version 34 results, 30 excluded, 4 duplicates PubMed: Cost-Benefit Analysis, Costs, Cost Control, Health Care Costs, Hospital Costs, AND Fetal Version 26 results, 19 excluded, 2 duplicates Net 21 Articles Net 0 Articles Net 5 Articles PubMed: Anesthesia, Spinal, Analgesia, Anesthesia, Combined Spinal Epidural, Neuraxial, AND Fetal Version, External Cephalic Version 45 Results, 17 excluded, 20 Duplicates Net 8 Articles OVID: Version, Fetal, Anesthesia 19 results, 13 Excluded Net 6 Articles Cochrane Systematic Reviews :External Cephalic Version, Breech 7 results, 5 excluded Net 2 Articles Manual examination of citations in reviewed publications and other sources 12 results Net 12 Articles TOTAL NET ARTICLES FOR INCLUSION 55 Figure 3. Literature selection flow sheet Resources and Project Cost Analysis Costs of the project were limited to office supplies as well as academic institutional tuition and fees borne by the author. Online access to East Carolina University’s library resources and other open source sites were utilized. The author has invested approximately four hundred hours amounting to a personnel expense, excluding input from faculty and academic committee members, of twenty-four thousand dollars. The timeline for the project is attached (see Appendix C). NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 21 This project is limited to the development of the agency specific clinical practice protocol. Post implementation assessment is a matter for future analysis whether by pilot study or prospective analysis of CD rate, cost, morbidity, as compared to previous events documented in patient records. Future work would include short and long-term evaluation of compliance. Results The current practice at NHCL includes formal consultation to an anesthesia provider, anesthesiologist or Certified Registered Nurse Anesthetist, by an obstetric provider for patients with certain comorbid conditions prior to admission. This process remains unchanged and criteria are listed in the amended NHCL Clinical Practice Guideline for Anesthesia Consultation Prior to Admission is presented (see Appendix D). In the past, pre-anesthetic evaluation and counseling for ECV was routinely conducted on the day of the procedure unless subsequent CD was planned following an unsuccessful ECV attempt. Based on the evidence and ACOG (2016) recommendation for utilization of CNB for ECV, Appendix D provides for anesthesia consultation for all patients with fetal BP at 36 weeks following the diagnosis and initial counseling by the attending obstetric provider. Anesthesia counseling is conducted in preparation for planned ECV at 37 weeks or later. The addition of pre-procedural consultation to anesthesia for ECV evaluation and counseling does not result in increased workload for anesthesia providers. It changes the sequence of events since all patients admitted for labor and delivery at NHCL are evaluated and consented for anesthetic intervention by an anesthesia provider. Obstetric patients presenting to anesthesia for pre-procedural visits are counseled on the risks, benefits, and potential complications of CNB as well as general anesthesia for labor and delivery. Consistent with ACOG’s practice bulletin, the added benefits of anesthesia in regards to alleviation of procedural pain and increased success rates of ECV with the placement NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 22 of a CNB are addressed during this counseling (ACOG, 2016). The complete process is described in proposed Clinical Practice Protocol, Management of Patients Receiving External Cephalic Version (see Appendix E). A formal presentation of the clinical evidence supporting the use of CNB to facilitate the success of ECV was presented to the anesthesia and obstetric departments’ staff. The goal of this early involvement was to allow for active engagement of members and open discourse concerning the paradigm change in anesthesia services from simply facilitating surgery to actively enhancing clinical outcomes of procedures. The obstetrics department chair addressed specific concerns and questions raised by obstetric practitioners that were outside the practice of anesthesia and are specifically related to obstetrical practice. These concerns included documentation of surgical history and physical and administrative process for outpatient admission for ECV procedure for patients at 37 gestational age without planned delivery. Additionally, the NHCL Board of Directors was briefed on the protocol as a process improvement initiative and board members offered positive commentary regarding risk management, fiscal soundness, women’s health, evidence-based practice, and expansion of services. The provision of anesthesia for ECV has not been universally practiced and ACOG advocacy for utilization of CNB for ECV was not expressed by ACOG until 2016 (ACOG, 2016). All anesthesia providers at NHCL have clinical privileges and provide CNB on a routine basis. The recent release of the ACOG practice bulletin promotes the benefits of CNB anesthesia in increasing the success rates of ECV and decreasing the CD rate (ACOG, 2016). Providing anesthesia, not only to alleviate pain, but also to augment and facilitate an increase in the success of ECV attempts may be conceptually foreign to many anesthesia and obstetrical providers. NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 23 The goal of this project was achieved. The Naval Hospital Camp Lejeune, Department of Anesthesia Clinical Practice Protocol, Management of Patients Receiving External Cephalic Version has received formal approval by all required signatories and was effective August 1, 2016. Discussion At NHCL, data concerning the success of ECV with and without anesthesia, as well as the rate for primary CD for BP has not been examined in the past. As a military treatment facility, NHCL’s patient population is highly mobile; as such long-term implications, morbidity, and patient outcomes are not always available. Despite the utilization of an inpatient electronic medical record, providers currently cannot access the information and associated data from other military treatment facilities in the network. Evaluation of immediate or short-term efficacy is possible. Data mining by CPT code is one mechanism to collect data concerning ECV, VD, and CD for NHCL. Since the evaluation would involve success or failure of ECV with and without anesthesia, all ECV procedures meet inclusion criteria for follow up evaluation. Additionally, NHCL’s inpatient electronic medical record includes a note template for providers to document the success or failure of ECV procedures with a single check box. This data entry point provides an opportunity to evaluate the individual and overall ECV success rate at NHCL. The development of an electronic data collection tool will provide a mechanism for further evaluation of implementation and efficacy of the clinical practice protocol. As a process improvement initiative, local implementation is the primary goal for this protocol. However, given similarities in the organizational structures and practice models within Navy Medicine there may be implications for broader dissemination and adoption at other naval hospitals. This project will be submitted for publication in the AANA Journal. Additionally, given the interprofessional subject NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 24 matter, application for publication in midwifery or women’s health journals will also be explored. The involvement of an OB/GYN physician in this author’s advisory committee provides an opportunity for interprofessional co-authorship and potential broader options for publication in medical journals. Summary Following the conceptual framework of the Iowa Model (see Figure 2) an extensive literature review was conducted and evidence supports utilization of CNB for ECV at term. As well, ACOG issued a practice bulletin advocating the use of CNB for ECV (ACOG, 2016). Using anesthesia to improve procedural outcomes, reduce healthcare costs, decrease maternal and neonatal morbidity, and enhance the quality of life for post partum women requires a paradigm shift for both anesthesia and obstetric providers. 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Journal of Perinatology : Official Journal of the California Perinatal Association, 30(9), 580-583. doi:10.1038/jp.2010.61 [doi] NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION Appendix A 33 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION Appendix B 34 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION Appendix C Project Timeline Semester 3 (May 18-July 31, 2015) Scholarly Practicum 1 June 15-16 DNP Intensives June 17 Library Day with Librarian June 23 Revision Abstract, submitted to BB June 25 Request letter of support to NHCL June 29 Committee chair and members finalized. Agreement Form Completed July 2 Letter of support follow up if not returned. July 8 Final Paper (including Committee Members) submitted July 28 Time Log to BB (100-hrs. minimum) Semester 4 (January 11- April 28, 2016) Scholarly Practicum 2 Jan 11 Start Lit review update (ongoing) Feb 8-10 DNP Intensives IRB application IRB Approval Submission Mar 21 First draft paper detailing the full project to BB and committee membership. Apr 18 Final paper detailing the full project to BB and committee membership. Apr 26 SP2 Time log to BB (150-hrs. minimum) Apr 26 Chair Approval for progression to SPIII Semester 5 May 16 June 13-15 July 5 July 29 Aug 1 (May 16- July 28, 2016) Scholarly Practicum 3 Start working on pre DNP Intensive deliverables DNP Intensives Presentation to NHCL Board of Directors Scholarly Practicum log to BB (125-hrs. minimum) Effective date of Protocol for NHCL Semester 6 (Aug 22- Dec 5, 2016) Scholarly Practicum 4 Aug 18 Presentation to Medical Executive Committee NHCL Sep 10 Dissemination Plan Submitted Sep 12-14 DNP Intensives Sep 28 Presentation to Nursing Executive Committee NHCL Nov 17 Formal Poster Presentation to CON Nov 28 Scholarly Practicum log to BB (125-hrs. minimum) TBD Article/Journal Submission 35 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION Appendix D 36 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 37 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION Appendix E 38 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 39 NEURAXIAL ANESTHESIA FOR EXTERNAL CEPHALIC VERSION 40