David M Greer1, Sam D Shemie2,3, Ariane Lewis4, Sylvia Torrance3, Panayiotis Varelas5, Fernando D Goldenberg6, James L Bernat7, Michael Souter8, Mehmet Akif Topcuoglu9, Anne W Alexandrov10, Marie Baldisseri11, Thomas Bleck12, Giuseppe Citerio13, Rosanne Dawson3, Arnold Hoppe14, Stephen Jacobe15, Alex Manara16, Thomas A Nakagawa17, Thaddeus Mason Pope18, William Silvester19, David Thomson20, Hussain Al Rahma21, Rafael Badenes22, Andrew J Baker23, Vladimir Cerny24, Cherylee Chang25, Tiffany R Chang26, Elena Gnedovskaya27, Moon-Ku Han28, Stephen Honeybul29, Edgar Jimenez30, Yasuhiro Kuroda31, Gang Liu32, Uzzwal Kumar Mallick33, Victoria Marquevich34, Jorge Mejia-Mantilla35, Michael Piradov27, Sarah Quayyum36, Gentle Sunder Shrestha37, Ying-Ying Su32, Shelly D Timmons38, Jeanne Teitelbaum39, Walter Videtta40, Kapil Zirpe41, Gene Sung42. 1. Boston University School of Medicine, Boston, Massachusetts. 2. McGill University, Montreal Children's Hospital, Montreal, Canada. 3. Canadian Blood Services, Ottawa, Canada. 4. NYU Langone Medical Center, New York, New York. 5. Albany Medical College, Albany, New York. 6. University of Chicago, Chicago, Illinois. 7. Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. 8. University of Washington, Seattle. 9. Department of Neurology, Hacettepe University, Ankara, Turkey. 10. College of Nursing, University of Tennessee Health Science Center, Memphis. 11. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 12. Northwestern University Feinberg School of Medicine, Chicago, Illinois. 13. University Milano-Bicocca, Milano-Bicocca, Italy. 14. Clínica Alemana, Universidad del Desarrollo, Santiago, Chile. 15. University of Sydney and Children's Hospital of Westmead, Westmead, Australia. 16. Southmead Hospital, Bristol, United Kingdom. 17. University of Florida, Jacksonville. 18. Mitchell Hamline School of Law, Saint Paul, Minnesota. 19. University of Melbourne, Melbourne, Australia. 20. University of Cape Town, Cape Town, South Africa. 21. Dubai Hospital, Dubai, United Arab Emirates. 22. Hospital Clinic Universitari, University of Valencia, Valencia, Spain. 23. St. Michael's Hospital, Unity Health Toronto and University of Toronto, Toronto, Canada. 24. J.E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic. 25. Queen's Medical Center, Honolulu, Hawaii. 26. The University of Texas Health Science Center at Houston, Houston. 27. Research Center of Neurology, Moscow, Russia. 28. Seoul National University Bundang Hospital, Seoul, Republic of Korea. 29. Sir Charles Gairdner Hospital, Nedlands, Australia. 30. Texas A&M, College Station. 31. Kagawa University, Kagawa, Japan. 32. Capital Medical University, Beijing, China. 33. National Institute of Neurosciences and Hospital, Dhaka, Bangladesh. 34. Hospital Universitario Austral, Buenos Aires, Argentina. 35. Fundación Valle del Lili, Cali, Colombia. 36. The University of Toronto, Toronto, Canada. 37. Tribhuvan University Teaching Hospital, Kathmandu, Nepal. 38. Indiana University, Indianapolis. 39. Montreal Neurological Institute, Montreal, Canada. 40. National Hospital, Alejandro Posadas, Buenos Aires, Argentina. 41. Ruby Hall Clinic, Pune, India. 42. University of Southern California, Los Angeles.
Abstract
IMPORTANCE: There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries. OBJECTIVE: To formulate a consensus statement of recommendations on determination of BD/DNC based on review of the literature and expert opinion of a large multidisciplinary, international panel. PROCESS: Relevant international professional societies were recruited to develop recommendations regarding determination of BD/DNC. Literature searches of the Cochrane, Embase, and MEDLINE databases included January 1, 1992, through April 2020 identified pertinent articles for review. Because of the lack of high-quality data from randomized clinical trials or large observational studies, recommendations were formulated based on consensus of contributors and medical societies that represented relevant disciplines, including critical care, neurology, and neurosurgery. EVIDENCE SYNTHESIS: Based on review of the literature and consensus from a large multidisciplinary, international panel, minimum clinical criteria needed to determine BD/DNC in various circumstances were developed. RECOMMENDATIONS: Prior to evaluating a patient for BD/DNC, the patient should have an established neurologic diagnosis that can lead to the complete and irreversible loss of all brain function, and conditions that may confound the clinical examination and diseases that may mimic BD/DNC should be excluded. Determination of BD/DNC can be done with a clinical examination that demonstrates coma, brainstem areflexia, and apnea. This is seen when (1) there is no evidence of arousal or awareness to maximal external stimulation, including noxious visual, auditory, and tactile stimulation; (2) pupils are fixed in a midsize or dilated position and are nonreactive to light; (3) corneal, oculocephalic, and oculovestibular reflexes are absent; (4) there is no facial movement to noxious stimulation; (5) the gag reflex is absent to bilateral posterior pharyngeal stimulation; (6) the cough reflex is absent to deep tracheal suctioning; (7) there is no brain-mediated motor response to noxious stimulation of the limbs; and (8) spontaneous respirations are not observed when apnea test targets reach pH <7.30 and Paco2 ≥60 mm Hg. If the clinical examination cannot be completed, ancillary testing may be considered with blood flow studies or electrophysiologic testing. Special consideration is needed for children, for persons receiving extracorporeal membrane oxygenation, and for those receiving therapeutic hypothermia, as well as for factors such as religious, societal, and cultural perspectives; legal requirements; and resource availability. CONCLUSIONS AND RELEVANCE: This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries.
IMPORTANCE: There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries. OBJECTIVE: To formulate a consensus statement of recommendations on determination of BD/DNC based on review of the literature and expert opinion of a large multidisciplinary, international panel. PROCESS: Relevant international professional societies were recruited to develop recommendations regarding determination of BD/DNC. Literature searches of the Cochrane, Embase, and MEDLINE databases included January 1, 1992, through April 2020 identified pertinent articles for review. Because of the lack of high-quality data from randomized clinical trials or large observational studies, recommendations were formulated based on consensus of contributors and medical societies that represented relevant disciplines, including critical care, neurology, and neurosurgery. EVIDENCE SYNTHESIS: Based on review of the literature and consensus from a large multidisciplinary, international panel, minimum clinical criteria needed to determine BD/DNC in various circumstances were developed. RECOMMENDATIONS: Prior to evaluating a patient for BD/DNC, the patient should have an established neurologic diagnosis that can lead to the complete and irreversible loss of all brain function, and conditions that may confound the clinical examination and diseases that may mimic BD/DNC should be excluded. Determination of BD/DNC can be done with a clinical examination that demonstrates coma, brainstem areflexia, and apnea. This is seen when (1) there is no evidence of arousal or awareness to maximal external stimulation, including noxious visual, auditory, and tactile stimulation; (2) pupils are fixed in a midsize or dilated position and are nonreactive to light; (3) corneal, oculocephalic, and oculovestibular reflexes are absent; (4) there is no facial movement to noxious stimulation; (5) the gag reflex is absent to bilateral posterior pharyngeal stimulation; (6) the cough reflex is absent to deep tracheal suctioning; (7) there is no brain-mediated motor response to noxious stimulation of the limbs; and (8) spontaneous respirations are not observed when apnea test targets reach pH <7.30 and Paco2 ≥60 mm Hg. If the clinical examination cannot be completed, ancillary testing may be considered with blood flow studies or electrophysiologic testing. Special consideration is needed for children, for persons receiving extracorporeal membrane oxygenation, and for those receiving therapeutic hypothermia, as well as for factors such as religious, societal, and cultural perspectives; legal requirements; and resource availability. CONCLUSIONS AND RELEVANCE: This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries.
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