To identify similarities and differences in protocols on determination of brain death/death by neurologic criteria (BD/DNC) around the world.
Methods
We collected and reviewed official national BD/DNC protocols from contacts around the world between January 2018 and April 2019.
Results
We communicated with contacts in 136 countries and found that 83 (61% of countries with contacts identified, 42% of the world) had BD/DNC protocols, 78 of which were unique. Protocols addressed the following prerequisites and provided differing instructions: drug clearance (64, 82%), temperature (61, 78%), laboratory values (56, 72%), observation period (37, 47%), and blood pressure (34, 44%). Protocols did not consistently identify the same components for the clinical examination of brain death; 70 (90%) included coma, 70 (90%) included the pupillary reflex, 68 (87%) included the corneal reflex, 67 (86%) included the oculovestibular reflex, 64 (82%) included the gag reflex, 62 (79%) included the cough reflex, 58 (74%) included the oculocephalic reflex, 37 (47%) included noxious stimulation to the face, and 22 (28%) included noxious stimulation to the limbs. Apnea testing was mentioned in 71 (91%) protocols; there was variability in the technique and target across protocols. Ancillary testing was included as a requirement for all determinations of BD/DNC in 22 (28%) protocols.
Conclusions
There is considerable variability in BD/DNC determination protocols around the world. Medical standards for death should be the same everywhere. We recommend that a worldwide consensus be reached on the minimum standards for BD/DNC.
Donation physicians are specialists with expertise in organ and tissue donation and have been recognized internationally as a key contributor to improving organ and tissue donation services. Subsequent to a 2011 Canadian Critical Care Society-Canadian Blood Services consultation, the donation physician role has been gradually implemented in Canada. These professionals are generally intensive care unit physicians with an enhanced focus and expertise in organ/tissue donation. They must manage the dual obligation of caring for dying patients and their families while providing and/or improving organ donation services. In anticipation of actual, potential or perceived ethical challenges with the role, Canadian Blood Services in partnership with the Canadian Medical Association organized the development of an evidence-informed consensus process of donation experts and bioethicists to produce an ethics guide. This guide includes overarching principles and benefits of the DP role, and recommendations in regard to communication with families, role disclosure, consent discussions, interprofessional conflicts, conscientious objection, death determination, donation specific clinical practices in neurological determination of death and donation after circulatory death, end-of-life care, performance metrics, resources and remuneration. Although this report is intended to inform donation physician practices, it is recognized that the recommendations may have applicability to other professionals (eg, physicians in intensive care, emergency medicine, neurology, neurosurgery, pulmonology) who may also participate in the end-of-life care of potential donors in various clinical settings. It is hoped that this guidance will assist practitioners and their sponsoring organizations in preserving their duty of care, protecting the interests of dying patients, and fulfilling best practices for organ and tissue donation.
This report summarizes the results of the first phase in the development of international guidelines for death determination, focusing on the biology of death and the dying process, developed by an invitational forum of international content experts and representatives of a number of professional societies. Precise terminology was developed in order to improve clarity in death discussion and debate. Critical events in the physiological sequences leading to cessation of neurological and/or circulatory function were constructed. It was agreed that death determination is primarily clinical and recommendations for preconditions, confounding factors, minimum clinical standards and additional testing were made. A single operational definition of human death was developed: 'the permanent loss of capacity for consciousness and all brainstem functions, as a consequence of permanent cessation of circulation or catastrophic brain injury'. In order to complete the project, in the next phase, a broader group of international stakeholders will develop clinical practice guidelines, based on comprehensive reviews and grading of the existing evidence.
We appreciate Dr. Machado's interest in our article.1 Variability in determination of brain death/death by neurologic criteria (BD/DNC) could lead to loss of public and professional trust in BD/DNC and create the potential for a person to be declared dead and then subsequently recover or to be considered dead in one place but alive in another. Because of recent highly publicized lawsuits related to BD/DNC—such as the case of Jahi McMath—the American Academy of Neurology and other medical stakeholders in BD/DNC have advocated for regulatory oversight to ensure policies on BD/DNC are uniform in all US healthcare institutions.2 Similarly, the intent of the World Brain Death Project is to establish minimum criteria for BD/DNC internationally, addressing the present variability—or lack of guidance—in BD/DNC determination in a number of complex situations including (1) patients with primary posterior fossa injuries, (2) patients on extracorporeal membrane oxygenation, and (3) patients treated with targeted temperature management.
This 2023 Clinical Practice Guideline provides the biomedical definition of death based on permanent cessation of brain function that applies to all persons, as well as recommendations for death determination by circulatory criteria for potential organ donors and death determination by neurologic criteria for all mechanically ventilated patients regardless of organ donation potential. This Guideline is endorsed by the Canadian Critical Care Society, the Canadian Medical Association, the Canadian Association of Critical Care Nurses, Canadian Anesthesiologists' Society, the Canadian Neurological Sciences Federation (representing the Canadian Neurological Society, Canadian Neurosurgical Society, Canadian Society of Clinical Neurophysiologists, Canadian Association of Child Neurology, Canadian Society of Neuroradiology, and Canadian Stroke Consortium), Canadian Blood Services, the Canadian Donation and Transplantation Research Program, the Canadian Association of Emergency Physicians, the Nurse Practitioners Association of Canada, and the Canadian Cardiovascular Critical Care Society.
In the version of this Article initially published, a versioning error led to a mistake in the third paragraph of the Discussion.In the text now reading "In our dataset, the most extreme and sustained increase in SARS-CoV-2 cases associated with school opening was in the South, where school opening was associated with a weekly increase in cases ranging from 9.8 to 21.3 per 100,000 people, " the range initially reported was "7.8 to 18.9 per 100,000." The results presented in the text and figures are unaffected.
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.
'%3e%3cpath fill='%23012169' d='M0 0v30h60V0z'/%3e%3cpath stroke='%23fff' stroke-width='6' d='m0 0 60 30m0-30L0 30'/%3e%3cpath stroke='%23C8102E' stroke-width='4' d='m0 0 60 30m0-30L0 30' clip-path='url(%23b)'/%3e%3cpath stroke='%23fff' stroke-width='10' d='M30 0v30M0 15h60'/%3e%3cpath stroke='%23C8102E' stroke-width='6' d='M30 0v30M0 15h60'/%3e%3c/g%3e%3c/svg%3e)