Guidelines For The Management Of Severe Traumatic Brain

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Guidelines for the Management ofSevere Traumatic Brain Injury4th EditionNancy Carney, PhDAnnette M. Totten, PhDCindy O'Reilly, BSJamie S. Ullman, MDGregory W. J. Hawryluk, MD, PhDMichael J. Bell, MDSusan L. Bratton, MDRandall Chesnut, MDOdette A. Harris, MD, MPHNiranjan Kissoon, MDAndres M. Rubiano, MDLori Shutter, MDRobert C. Tasker, MBBS, MDMonica S. Vavilala, MDJack Wilberger, MDDavid W. Wright, MDJamshid Ghajar, MD, PhDOregon Health & Science University, Portland, OROregon Health & Science University, Portland, OROregon Health & Science University, Portland, ORHofstra North Shore-LIJ School of Medicine, Hempstead, NYUniversity of Utah, Salt Lake City, UTUniversity of Pittsburgh, Pittsburgh, PAUniversity of Utah, Salt Lake City, UTUniversity of Washington, Seattle, WAStanford University, Stanford, CAUniversity of British Columbia, Vancouver, BCEl Bosque University, Bogota, Colombia; MEDITECHFoundation, Neiva, ColombiaUniversity of Pittsburgh, Pittsburgh, PAHarvard Medical School & Boston Children’s Hospital,Boston, MAUniversity of Washington, Seattle, WADrexel University, Pittsburgh, PAEmory University, Atlanta, GAStanford University, Stanford, CAReviewed for evidence-based integrity and endorsed by the American Association ofNeurological Surgeons and the Congress of Neurological Surgeons.September 2016

TABLE OF CONTENTSPREFACE . 5ACKNOWLEDGEMENTS .5FUNDING SOURCE .6DISCLAIMER OF LIABILITY .6CONFLICT OF INTEREST DISCLOSURE .7AUTHORS’ PREFACE .7INTRODUCTION. 8BRAIN TRAUMA RESEARCH: CURRENT CONDITIONS .8THE BRAIN TRAUMA FOUNDATION’S POSITION .9THE BRAIN TRAUMA EVIDENCE-BASED CONSORTIUM . 12METHODS . 14SYSTEMATIC EVIDENCE REVIEW AND SYNTHESIS . 14DEVELOPMENT OF RECOMMENDATIONS . 22EVIDENCE SYNTHESIS AND RECOMMENDATIONS, PART I: TREATMENTS. 251.2.3.4.5.6.7.8.9.10.11.DECOMPRESSIVE CRANIECTOMY . 26PROPHYLACTIC HYPOTHERMIA . 36HYPEROSMOLAR THERAPY . 49CEREBROSPINAL FLUID DRAINAGE . 57VENTILATION THERAPIES . 62ANESTHETICS, ANALGESICS, AND SEDATIVES . 67STEROIDS . 76NUTRITION . 84INFECTION PROPHYLAXIS. 99DEEP VEIN THROMBOSIS PROPHYLAXIS . 111SEIZURE PROPHYLAXIS . 120EVIDENCE SYNTHESIS AND RECOMMENDATIONS, PART II: MONITORING . 13012.13.14.INTRACRANIAL PRESSURE MONITORING . 132CEREBRAL PERFUSION PRESSURE MONITORING . 145ADVANCED CEREBRAL MONITORING . 151EVIDENCE SYNTHESIS AND RECOMMENDATIONS, PART III: THRESHOLDS . 16315.16.17.18.BLOOD PRESSURE THRESHOLDS . 164INTRACRANIAL PRESSURE THRESHOLDS . 172CEREBRAL PERFUSION PRESSURE THRESHOLDS . 181ADVANCED CEREBRAL MONITORING THRESHOLDS. 191FUTURE RESEARCH . 201TOPIC SELECTION AND REFINEMENT . 201METHODS—INDIVIDUAL STUDIES . 202METHODS—SYSTEMATIC REVIEWS AND GUIDELINES DEVELOPMENT. 203CONCLUSION . 2052

TABLESTABLE 1-1. QUALITY OF THE BODY OF EVIDENCE (DEPRESSIVE CRANIECTOMY) . 28TABLE 1-2. SUMMARY OF EVIDENCE – CLASS 1 AND 2 STUDIES (DEPRESSIVE CRANIECTOMY) . 29TABLE 1-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (DEPRESSIVE CRANIECTOMY) . 31TABLE 2-1. QUALITY OF THE BODY OF EVIDENCE (PROPHYLACTIC HYPOTHERMIA) . 37TABLE 2-2. SUMMARY OF EVIDENCE – CLASS 1 AND 2 STUDIES (PROPHYLACTIC HYPOTHERMIA) . 39TABLE 2-3. SUMMARY OF EVIDENCE–CLASS 3 STUDIES (PROPHYLACTIC HYPOTHERMIA) . 44TABLE 3-1. QUALITY OF THE BODY OF EVIDENCE (HYPEROSMOLAR THERAPY) . 51TABLE 3-2. SUMMARY OF EVIDENCE - CLASS 2 (HYPEROSMOLAR THERAPY) . 52TABLE 3-3. SUMMARY OF EVIDENCE–CLASS 3 STUDIES (HYPEROSMOLAR THERAPY) . 54TABLE 4-1. QUALITY OF THE BODY OF EVIDENCE (CEREBROSPINAL FLUID DRAINAGE). 58TABLE 4-2. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (CEREBROSPINAL FLUID DRAINAGE) . 59TABLE 5-1. QUALITY OF THE BODY OF EVIDENCE (VENTILATION THERAPIES) . 64TABLE 5-2. SUMMARY OF EVIDENCE (VENTILATION THERAPIES) . 65TABLE 6-1. QUALITY OF THE BODY OF EVIDENCE (ANESTHETICS, ANALGESICS, AND SEDATIVES) . 69TABLE 6-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES (ANESTHETICS, ANALGESICS, AND SEDATIVES) . 70TABLE 6-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (ANESTHETICS, ANALGESICS, AND SEDATIVES) . 72TABLE 7-1. QUALITY OF THE BODY OF EVIDENCE (STEROIDS) . 77TABLE 7-2. SUMMARY OF EVIDENCE: CLASS 1 AND 2 STUDIES (STEROIDS) . 78TABLE 7-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (STEROIDS) . 81TABLE 8-1. QUALITY OF THE BODY OF EVIDENCE (NUTRITION) . 86TABLE 8-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES (NUTRITION) . 87TABLE 8-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (NUTRITION) . 91TABLE 9-1. QUALITY OF THE BODY OF EVIDENCE (INFECTION PROPHYLAXIS) . 101TABLE 9-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES AND META-ANALYSES (INFECTION PROPHYLAXIS) . 103TABLE 9-3. SUMMARY OF EVIDENCE: CLASS 3 STUDIES (INFECTION PROPHYLAXIS) . 107TABLE 10-1. QUALITY OF BODY OF EVIDENCE (DEEP VEIN THROMBOSIS PROPHYLAXIS) . 113TABLE 10-2. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (DEEP VEIN THROMBOSIS PROPHYLAXIS) . 114TABLE 11-1. QUALITY OF BODY OF EVIDENCE (SEIZURE PROPHYLAXIS) . 122TABLE 11-2. SUMMARY OF EVIDENCE – CLASS 2 STUDIES (SEIZURE PROPHYLAXIS) . 123TABLE 11-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (SEIZURE PROPHYLAXIS) . 126TABLE 12-1. QUALITY OF THE BODY OF EVIDENCE (INTRACRANIAL PRESSURE MONITORING) . 134TABLE 12-2. SUMMARY OF EVIDENCE: CLASS 1 AND 2 STUDIES (INTRACRANIAL PRESSURE MONITORING). 135TABLE 12-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (INTRACRANIAL PRESSURE MONITORING) . 140TABLE 13-1. QUALITY OF THE BODY OF EVIDENCE (CEREBRAL PERFUSION PRESSURE MONITORING) . 146TABLE 13-2. SUMMARY OF EVIDENCE – CLASS 2 STUDY (CEREBRAL PERFUSION PRESSURE MONITORING) . 147TABLE 13-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (CEREBRAL PERFUSION PRESSURE MONITORING) . 148TABLE 14-1. QUALITY OF THE BODY OF EVIDENCE (ADVANCED CEREBRAL MONITORING) . 153TABLE 14-2. SUMMARY OF EVIDENCE: CLASS 2 STUDY (ADVANCED CEREBRAL MONITORING) . 154TABLE 14-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (ADVANCED CEREBRAL MONITORING) . 155TABLE 15-1. QUALITY OF THE BODY OF EVIDENCE (BLOOD PRESSURE THRESHOLDS) . 165TABLE 15-2. SUMMARY OF EVIDENCE – CLASS 2 STUDY (BLOOD PRESSURE THRESHOLDS) . 166TABLE 15-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (BLOOD PRESSURE THRESHOLDS) . 167TABLE 16-1. QUALITY OF THE BODY OF EVIDENCE (INTRACRANIAL PRESSURE THRESHOLDS) . 174TABLE 16-2. SUMMARY OF EVIDENCE – CLASS 2 STUDY (INTRACRANIAL PRESSURE THRESHOLDS) . 175TABLE 16-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (INTRACRANIAL PRESSURE THRESHOLDS) . 176TABLE 17-1. QUALITY OF THE BODY OF EVIDENCE (CEREBRAL PERFUSION PRESSURE THRESHOLDS) . 183TABLE 17-2. SUMMARY OF EVIDENCE – CLASS 2 STUDIES (CEREBRAL PERFUSION PRESSURE THRESHOLDS) . 184TABLE 17-3. SUMMARY OF EVIDENCE – CLASS 3 STUDIES (CEREBRAL PERFUSION PRESSURE THRESHOLDS) . 185TABLE 18-1. QUALITY OF THE BODY OF EVIDENCE (ADVANCED CEREBRAL MONITORING THRESHOLDS) . 192TABLE 18-2. SUMMARY OF EVIDENCE: CLASS 2 STUDIES (ADVANCED CEREBRAL MONITORING THRESHOLDS) . 194TABLE 18-3: SUMMARY OF EVIDENCE: CLASS 3 STUDIES (ADVANCED CEREBRAL MONITORING THRESHOLDS) . 1953

APPENDICESAPPENDIX A. MAJOR CHANGES FROM 3RD TO 4TH EDITION . 207APPENDIX B. RESEARCH TEAM . 210APPENDIX C. ANALYTIC FRAMEWORKS . 211APPENDIX D. SEARCH STRATEGIES . 215APPENDIX E. INCLUSION AND EXCLUSION CRITERIA . 223APPENDIX F. EXCLUDED STUDIES . 225APPENDIX G. CRITERIA FOR QUALITY ASSESSMENT OF INDIVIDUAL STUDIES . 240APPENDIX H. QUALITY OF THE BODY OF EVIDENCE ASSESSMENT . 242APPENDIX I. HYPOTHERMIA INTERVENTIONS DETAIL . 2444

PrefaceAcknowledgementsWe would like to thank the following people at the Pacific Northwest Evidence-basedPractice Center at Oregon Health & Science University for their invaluable assistance inproducing this document: Molly Stillwell, MA, Ngoc Wasson, MPH, Sandra Assasnik, MA,Elaine Graham, MLS, Leah Williams, BS, and Roger Chou, MD; we also thank Stephanie A.Kolakowsky-Hayner, PhD, and Meredith Klein, MS, from the Brain Trauma Foundation for theirreview of the document.Additionally, we would like to thank the following people for serving as peer reviewers andproviding their insights, comments, and suggestions:Mary Kay Bader, RN, Neuroscience Nurse’s Association; Mission Hospital, Mission Viejo, CARoss Bullock, MD, PhD, Medical Advisory Board, Brain Trauma Foundation; University ofMiami, Miami, FLJamie Cooper, MD, Australian and New Zealand Intensive Care Research Centre, MonashUniversity, Melbourne, Victoria, AustraliaChris Cribari, MD, American College of Surgeons Committee on Trauma; University ofColorado, Boulder, CORachel Groman, MPH, Quality Improvement and Research, American Association ofNeurological Surgeons/Congress of Neurological Surgeons, Washington, DCKaren Hirsch, MD, Neurology, Stanford School of Medicine, Palo Alto, CAStephan Mayer, MD, Neurocritical Care Society; Mount Sinai, New York, NYEnrique Noé, MD, PhD, Neurology, Hospital NISA, Valecnia al Mar and Sevilla-Aljarafe, SpainGustavo Petroni, MD, Hospital de Emergencias Dr. Clemente Alvarez, Rosario, Santa Fe,ArgentinaP.B. Raksin, MD, Neurosurgery, John H. Stroger Jr. Hospital of Cook County, Chicago, IL,Gerard Ribbers, MD, PhD, Rehabilitation Medicine, Erasmus University of Rotterdam,Rotterdam, Netherlands5

Alex Valadka, MD, American Association of Neurological Surgeons; National Trauma Institute;Seton Brain and Spine Institute, Austin, TX (presently at Virginia Commonwealth University,Richmond, VA)Finally, we would like to recognize the American Association of Neurological Surgeons(AANS) and the Congress of Neurological Surgeons (CNS) Joint Guidelines Committee (JGC)for providing feedback on the Guidelines for the Management of Severe Traumatic Brain Injury,4th Edition, and the AANS and CNS leadership for their endorsement, which appears on the titlepage.Funding SourceThis material is based in part upon work supported by (1) the U.S. Army ContractingCommand, Aberdeen Proving Ground, Natick Contracting Division, through a contract awardedto Stanford University (W911 QY-14-C-0086), a subcontract awarded to the Brain TraumaFoundation, and a second-tier subcontract awarded to Oregon Health & Science University and(2) the Brain Trauma Foundation, through a contract awarded to Oregon Health & ScienceUniversity.Any opinions, findings and conclusions or recommendations expressed in this material arethose of the authors and do not necessarily reflect the views of the U.S. Army ContractingCommand, Aberdeen Proving Ground, Natick Contracting Division, Stanford University, or theBrain Trauma Foundation.Disclaimer of LiabilityThe information contained in the Guidelines for the Management of Severe Traumatic BrainInjury reflects the current state of knowledge at the time of publication. The Brain TraumaFoundation, American Association of Neurological Surgeons, Congress of NeurologicalSurgeons, and other collaborating organizations are not engaged in rendering professionalmedical services and assume no responsibility for patient outcomes resulting from application ofthese general recommendations in specific patient circumstances. Accordingly, the Brain TraumaFoundation, American Association of Neurological Surgeons, and Congress of NeurologicalSurgeons consider adherence to these clinical practice guidelines will not necessarily assure a6

successful medical outcome. The information contained in these guidelines reflects publishedscientific evidence at the time of completion of the guidelines and cannot anticipate subsequentfindings and/or additional evidence, and therefore should not be considered inclusive of allproper procedures and tests or exclusive of other procedures and tests that are reasonablydirected to obtaining the same result. Medical advice and decisions are appropriately made onlyby a competent and licensed physician who must make decisions in light of all the facts andcircumstances in each individual and particular case and on the basis of availability of resourcesand expertise. Guidelines are not intended to supplant physician judgment with respect toparticular patients or special clinical situations and are not a substitute for physician-patientconsultation. Accordingly, the Brain Trauma Foundation, American Association of NeurologicalSurgeons, and Congress of Neurological Surgeons consider adherence to these guidelines to bevoluntary, with the ultimate determination regarding their application to be made by thephysician in light of each patient’s individual circumstances.Conflict of Interest DisclosureThere are no conflicts of interest. The authors have no personal, financial, or institutionalinterest in any of the drugs, materials, or devices described in this publication.Authors’ PrefaceThe scope and purpose of this work is two-fold: to synthesize the available evidence and totranslate it into recommendations. This document provides recommendations only when there isevidence to support them. As such, they do not constitute a complete protocol for clinical use.Our intention is that these recommendations be used by others to develop treatment protocols,which necessarily need to incorporate consensus and clinical judgment in areas where currentevidence is lacking or insufficient. We believe it is important to have evidence-basedrecommendations in order to clarify what aspects of practice currently can and cannot besupported by evidence, to encourage use of evidence-based treatments that exist, and toencourage creativity in treatment and research in areas where evidence does not exist. Thecommunities of

4th Edition Nancy Carney, PhD Oregon Health & Science University, Portland, OR . Annette M. Totten, PhD Oregon Health & Science University , Portland, OR . Cindy O'Reilly, BS Oregon Health & Science University, Portland, OR . Jamie S. Ullman, MD

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