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Brain arrest: the neurological determination of death and organ donor management in Canada
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     The management of patients with severe brain injury falls within the disciplines of emergency medical services, trauma, critical care, neurology and neurosurgery. Consultation and collaboration between professionals in these disciplines and those involved in end-of-life care and organ donation and transplantation are required to standardize and optimize the management of severely brain-injured patients who progress to neurological death.

    Brain death is better understood as brain arrest, or the final clinical expression of complete and irreversible neurological failure. Despite widespread national, international and legal acceptance of the concept of death as defined by neurological criteria, substantial variation exists in the standards and their application.1–5 In all Canadian provinces and territories, the legal definition of brain death is "according to accepted medical practice." These practices are largely determined by individual hospitals or regions. Guidelines established by the Canadian Congress Committee on Brain Death in 19886 and the Canadian Neurocritical Care Group in 1997 initiated clarification of the criteria, but have not led to uniform practice.

    Acknowledging this variation in the recognition, diagnosis and documentation of neurological death, the Canadian Council for Donation and Transplantation sponsored a national forum of experts to create a set of recommendations that will have significant implications for organ donation in Canada. Severe brain injury is a prerequisite for neurological determination of death (NDD); and NDD, commonly referred to as brain death, is a prerequisite for cadaveric organ donation. The right to entertain the option of organ and tissue donation is increasingly supported by society and will become legislated in some Canadian jurisdictions. Collaborative efforts are required to optimize the care of patients who may become eligible for donation and to ensure consistent and ethical conduct in care. This comprehensive national collaboration is the first of its kind in Canada in this domain.

    Forum overview

    The purpose of the forum "Severe Brain Injury to Neurological Determination of Death," held in Vancouver from 9 to 11 April 2003, was to initiate the development of a national agreement on the processes of care, commencing with severe brain injury and culminating with NDD. A priori, the forum accepted brain death as a medical and legal concept of death in Canadian society and restricted the discussion to optimum practice in the field. Objectives were

    ? To review national and international legislation, policies and practices related to NDD

    ? To prepare a made-in-Canada definition of NDD for children and adults, to ensure consistency and reliability in its diagnosis, declaration, documentation and reporting

    ? To discuss and agree on policies and practices in relation to emergency department, neurological, neurosurgical and intensive care unit (ICU) management of critically injured patients with a poor neurological prognosis

    ? To develop recommendations for the Canadian Council for Donation and Transplantation and other interested organizations and groups on the dissemination of these definitions, policies and practices across Canada.

    The forum was attended by 89 experts, including emergency, trauma and critical care physicians, neurologists, neurosurgeons, nurses and advanced nurse practitioners, as well as representatives of licensing colleges and donation–transplant agencies, health administrators, policy-makers, coroners, experts in end-of-life care and ethicists — a multidisciplinary group representing all regions of the country. Discussions focused on collaboration at a national level.

    Each of the 3 main areas of focus — recommendations for a Canadian definition, criteria and minimum testing requirements for NDD; recommendations concerning the incidence and reporting of NDD and legal issues; and recommendations associated with the management of patients with severe brain injury from the emergency department to the intensive care unit — was addressed using the following process. Presentations by experts were followed by plenary discussions supported by fact sheets that summarized preceding American8 and Canadian guidelines7 and by substantial background papers9–11 and surveys12 provided by the planning committee in advance of the forum. Small-group discussions then focused on specific questions related to the processes of care. The Forum Recommendations Group (FRG) and the Pediatric Reference Group (PRG) reviewed the results of the small-group discussions, developed unanimous recommendations for adults and children and returned these for plenary discussion. A Neonatal Reference Group met subsequent to the forum to develop neonatal age-adjusted recommendations. (See Appendix 1 for a list of members of these groups.) Clinical checklists are included in Appendix 4.

    Discussions at the forum were intense, rich in content and collegial. Members of the FRG and PRG panels unanimously agreed on recommendations that mark a significant advance on existing guidelines. Group members were invited to sit on these panels, both as representatives of their professional associations and as respected practitioners providing the benefit of their experience and expertise. Both panels were assisted by an external, objective facilitator.

    Forum recommendations were developed for infants, children, adolescents and adults. Drs. Paul Byrne and Sam Shemie were members of both the FRG and PRG and provided consistent pediatric input during the development of guidelines in plenary sessions and at FRG and PRG meetings.

    General considerations

    During discussions, FRG and PRG members recognized that

    ? Recommendations must be in the best interests of patients with severe brain injury.

    ? Optimum end-of-life care is a priority for all patients who may die after severe brain injuries.

    ? The wishes of patients and their families are of paramount importance.

    ? There is a need to clarify and standardize terminology, e.g., ancillary and supplementary testing, brain death (NDD, neurologically determined death or death by neurological determination [see Appendix 2 and Appendix 3].)

    ? The current evidence base for existing NDD guidelines is inadequate.

    ? Clear medical standards for NDD and defining qualifications of physicians performing NDD augment the quality and rigour of the determination.

    Overarching recommendations

    In discussions related to Recommendations A.4: Apnea testing, A.5: Examination interval and A.7: Concept and definition of neurological death, FRG members identified the following overarching recommendations, which apply to all of the individual recommendations:

    ? We recommend that after NDD, the patient be declared dead.

    ? Existing provincial and territorial laws indicate that for the purposes of a post-mortem transplant, the fact of death shall be determined by at least 2 physicians in accordance with accepted medical practice. There is no clear medical basis for the law requiring a second physician to determine death before post-mortem transplantation.

    ? The first and second physicians' determinations, required by law, may be performed concurrently. However, if the determinations are performed at different times, a full clinical examination, including apnea testing, must be performed at each determination. No fixed interval of time is recommended for the second determination, except where age-related criteria apply.

    ? The following codicil is required to address severe lung disease: Caution must be exercised in considering the validity of the apnea test if, in the physician's judgment, there is a history suggestive of chronic respiratory insufficiency and responsiveness to only supranormal levels of carbon dioxide, or if the patient is dependent on hypoxic drive. If the physician cannot be sure of the validity of the apnea test, an ancillary test should be administered.

    Recommendation A.5: Examination interval

    We recommend that when a second determination is performed, there should be no fixed examination interval, regardless of the primary mechanism of the brain injury.

    Recommendation A.6: Ancillary tests

    We recommend that an ancillary test be performed when it is impossible to complete the minimum clinical criteria as defined in Recommendation A.1. At a minimum, 2 particular clinical criteria must be met before ancillary tests are performed:

    ? An established etiology capable of causing neurological death in the absence of reversible conditions capable of mimicking neurological death

    ? Deep unresponsive coma

    We recommend that demonstration of the global absence of intracerebral blood flow be considered as the standard for NDD by ancillary testing.

    Key considerations

    ? Before performing an ancillary test, unresuscitated shock and hypothermia must be corrected (see Recommendation A.2).

    ? The term "ancillary" should be understood to mean an alternative test to one that otherwise, for any reason, cannot be conducted. It replaces previous terminology such as "supplemental" (in addition to an already conducted test) or "confirmatory" (confirms a previously conducted test).

    Existing evidence, although not firmly established, suggests that for patients who fulfill minimum clinical criteria (see Recommendation A.1) under the circumstances of high-dose barbiturate therapy used for refractory intracranial hypertension to achieve deep coma or electrocerebral silence, NDD can be confirmed by the demonstration of absence of intracerebral blood flow.14

    ? A description of ancillary testing is provided in Appendix 3 .

    Recommendation A.7: Concept and definition of neurological death

    We recommend that neurologically determined death be defined as the irreversible loss of the capacity for consciousness combined with the irreversible loss of all brain stem functions (as defined in Recommendation A.1), including the capacity to breathe.

    Key consideration

    Death determined by neurological criteria may occur as a consequence of intracranial hypertension or primary direct brain stem injury or both. In instances of intracranial hypertension, ancillary testing demonstrating absence of intracerebral blood flow confirms death when application of minimum clinical criteria (as defined in Recommendation A.1) cannot be completed, or if the interpretation of clinical criteria is confounded. There are currently no satisfactory ancillary tests for confirmation of neurologically determined death in instances of isolated primary brain stem injury.

    Key considerations

    ? Physicians should be required to report NDD through a single mechanism.

    ? Specific provisions for reporting NDD should be included on the medical certificate of death. If the NDD portion of the certificate is not completed, it should be returned to the physician for completion.

    Recommendation B.4: Legal issues

    We recommend that Canadian medical requirements for NDD (determined at this forum) be embodied in medical standards and clinical practice guidelines.

    Key consideration

    Hospital practices related to NDD vary across the country. There is a need to align them (e.g., accreditation) with medical standards and clinical practice guidelines related to NDD.

    C. Severe brain injury: from emergency department to ICU

    Recommendation C.1: Recognition of NDD

    We recommend that all patients who are suspected of being brain dead be assessed for NDD unless this has no implications for prognostication or management, including end-of-life care (see Recommendation C.3).

    Recommendation C.2: Emergency department to ICU triage — evolving neuroprotective therapies

    We recommend that all patients with severe brain injury who may benefit from treatment, prognostication or optimal end-of-life care within an ICU have access to these services.

    Key considerations

    ? Patient and family wishes must be considered, e.g., wishes made known during clinician consultations, in advance directives, on organ donor cards and to an organ donor registry.

    ? ICU is defined as care provided in an ICU, not critical care offered in an emergency department.

    ? Access to ICU services for patients with severe brain injury should be in addition to preserving access to ICU for other critically ill patients.

    ? Resource and societal issues require consideration.

    ? Clinicians need to have some flexibility in decision-making.

    Recommendation C.3: End-of-life care

    We recommend that for patients who die as a result of severe brain injury, standard postmortem care should include the option of organ and tissue donation for eligible patients.

    See also Appendix 5 and Appendix 6.

    Footnotes

    See Appendix 1 for a complete list of forum participants.

    This article has been peer reviewed.

    Acknowledgements: These recommendations have been endorsed by the Canadian Critical Care Society, Canadian Association of Emergency Physicians, Canadian Neurological Society, Canadian Neurosurgical Society (recommendations A and B), Canadian Neurocritical Care Group, Conference of Chief Coroners and Medical Examiners of Canada, Canadian Association of Critical Care Nurses, Canadian Association of Transplantation, Canadian Society of Transplantation, Quebec Transplant, Trillium Gift of Life Network and its ICU Advisory Group, Alberta HOPE Programs, Newfoundland OPEN Program, Transplant Atlantic, New Brunswick Transplant and the Canadian Council for Donation and Transplantation.

    The authors wish to acknowledge the financial support of the Canadian Council for Donation and Transplantation and the process consultation provided by Strachan-Tomlinson and Associates.

    Competing interests: None declared.

    Reprint requests to: Ms. Kimberly Young, Canadian Council for Donation and Transplantation, 1702–8215 112 St., Edmonton AB T6G 2C8; 780 409-5652; kimberly.young@ccdt.ca

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