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COUNTERPOINT: Should Informed Consent Be Required for Apnea Testing in Patients With Suspected Brain Death? Yes

2017; Elsevier BV; Volume: 152; Issue: 4 Linguagem: Inglês

10.1016/j.chest.2017.05.032

1931-3543

Robert D. Truog, Robert C. Tasker,

Grief, Bereavement, and Mental Health

Is it necessary to seek the informed consent of the patient's surrogate when performing an apnea test as part of the examination for brain death? The question is particularly timely, not only because of recent legal decisions that have come down on different sides of the issue,1ThaddeusPope.com. Court cases concerning consent for diagnostic brain death testing. http://www.thaddeuspope.com/braindeath/apneaconsent.html. Accessed April 24, 2017.Google Scholar but also because of a number of cases where families have rejected the diagnosis of brain death after it was determined, and likely would have refused testing had they been asked.2ThaddeusPope.com. Brain death resources. http://www.thaddeuspope.com/braindeath.html. Accessed April 24, 2017.Google Scholar And while we will focus on the apnea test, we should note that when patients are not candidates for a clinical examination (because of physiologic instability, direct injury to cranial nerves, presence of sedatives, etc.), then ancillary tests may be necessary, raising the same questions about the need for informed consent with equal relevance and urgency. We recognize that many clinicians will bristle at the idea that they must obtain informed consent in order to make a medical diagnosis. But we think there are several reasonable and legitimate grounds for thinking that physicians should be required to do so, and for why it is not unreasonable for surrogates to sometimes say no. First, the literature shows that apnea testing can be associated with serious complications, including hemodynamic instability, tension pneumothorax, pneumomediastinum, cardiac arrhythmias, and cardiac arrest, among others. One series of 70 apnea tests, reportedly performed in accordance with the 2010 guidelines,3Jeret J.S. Evidence-based guideline update: determining brain death in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology.Neurology. 2011; 76: 307-308Crossref PubMed Scopus (1) Google Scholar found that 39% of patients either developed marked hypotension or required prophylactic administration of vasopressors to maintain hemodynamic stability.4Jeret J.S. Benjamin J.L. Risk of hypotension during apnea testing.Arch Neurol. 1994; 51: 595-599Crossref PubMed Scopus (54) Google Scholar While strict adherence to published guidelines may mitigate the risks associated with apnea testing, in standard clinical practice any risks from a procedure can be justified only by commensurate benefits to the patient. Apnea testing never provides any direct medical benefits to a patient; the only benefit of the test would be the cessation of continued treatment to someone diagnosed as dead. But when surrogates, who are charged with representing the views and interests of the patient, see cessation of treatment as a harm and not a benefit, the argument in favor of a benefit fails. In addition to the risk of complications that may result in immediate harm to the patient, the apnea test may confer a more insidious risk, that is, the risk associated with an acute rise in partial pressure of carbon dioxide and consequent cardiovascular changes, which may result in a further rise in intracranial pressure. Roth and colleagues5Roth C. Deinsberger W. Kleffmann J. Ferbert A. Intracranial pressure and cerebral perfusion pressure during apnoea testing for the diagnosis of brain death: an observational study.Eur J Neurol. 2015; 22: 1208-1214Crossref PubMed Scopus (24) Google Scholar recently studied 16 apnea tests in 13 patients. The authors found a significant increase in intracranial pressure during the testing. Such elevation is an important marker of secondary brain injury in patients who have suffered neurologic insults. More importantly for this discussion, however, is the fact that changes in cerebral hemodynamics and hydrodynamics may not result in an immediately recognized complication, but may cause secondary injury such that patients who do not meet the criteria for brain death on initial testing might subsequently be made brain dead as a result of the testing. Since the test is performed before it is known that the patient is brain dead, the risk here is that a test intended to determine whether a patient is dead may, in fact, cause death. Some might argue that we do not routinely seek consent for other tests that we perform in the ICU, and that the apnea test should not be singled out as an exception. But this view misunderstands the circumstances under which we are obliged to obtain informed consent. Outside of emergency situations, informed consent is required for everything we do to patients, from taking their pulse to performing surgery. Patients provide a general consent to treatment at the time of admission, and this covers all tests and procedures where we can reasonably assume that the patient would regard the benefits of the procedure as sufficient to outweigh any risks or harms. But whenever we cannot safely assume that the patient would want the procedure, we have an ethical and legal obligation to seek the informed consent of the patient or surrogate. Since apnea testing offers no therapeutic benefit to the patient, and may in fact involve potentially life-threatening risks and harms, consent for the procedure would seem to be essential. Others might claim that hospitals have a fundamental "right" to know whether patients are alive or dead. But this bold assertion needs to be unpacked and examined in some detail. If there is such a right, then it would be justified by the claim that hospitals have a duty to ensure that ICU resources are not being wasted on patients who are unable to benefit from them, and that hospitals are therefore justified in forcing a potentially harmful test on patients in order to optimize the use of scarce resources. This claim would, in turn, be founded on the assumption that allowing patients and families to refuse apnea testing would necessarily burden our ICUs with the long-term care of legally dead patients whose families refuse to accept that they are dead, thereby denying life-saving medical resources to those who could benefit from them. But how realistic is this assumption? New Jersey has granted a religious objection for those who reject the diagnosis of brain death. In these cases, "death shall be declared, and the time of death fixed, solely upon the basis of cardio-respiratory criteria."6Olick R.S. Brain death, religious freedom, and public policy: New Jersey's landmark legislative initiative.Kennedy Inst Ethics J. 1991; 1: 275-288Crossref PubMed Scopus (69) Google Scholar To our knowledge, in the more than 25 years that this law has been in effect, ICUs in New Jersey have not been disproportionately burdened with care of the brain dead. And while international comparisons are tricky, there is no evidence that ICUs in countries that routinely permit families to reject the diagnosis of brain death (eg, Japan and Israel) are significantly hindered by giving deference to these views. One report extrapolated from Japanese data to estimate the effect of adopting the Japanese approach in the United States, and concluded that such a policy would result in no more than four to nine cases of "prolonged support" of brain-dead patients in the United States each year.7Muramoto O. Informed consent for the diagnosis of brain death: a conceptual argument.Philos Ethics Humanit Med. 2016; 11: 8Crossref PubMed Scopus (8) Google Scholar On reflection, this analysis should not be surprising—the vast majority of patients and families do not want to receive nonbeneficial care any more than clinicians want to provide it. But in any case, there is no evidence that giving patients and families the right to reject the diagnosis of brain death would have a significant impact on the utilization of ICU resources in this country. In addition, a number of diverse religious groups, including some Christians, Orthodox Jews, Shintoists, Buddhists, and Muslims, believe that death does not occur until the heart stops beating. There is nothing illogical, irrational, or immoral about this view. Indeed, this ambivalence is reflected in the laws and customs of many countries. In many Asian countries, for example, brain death is not widely accepted as death. In Japan, families are given a choice about whether to have death defined by neurologic or by cardiorespiratory criteria. In practice, brain death is determined only when a transplantation is to be performed.8Japan Organ Transplant Network. Views on brain death. https://www.jotnw.or.jp/english/05.html. Accessed April 24, 2017.Google Scholar As the world becomes a more global community, our hospitals are increasingly encountering patients and families who do not share the dominant values and traditions of our culture. While our society has no obligation to give deference to minority religious or cultural beliefs and norms, we should not violate them lightly or without just cause. In conclusion, while it has not been customary to seek the informed consent of the patient's surrogate before performing the apnea test, we argue that such consent is necessary, because the harms of the procedure may be severe and exceed the benefits, because doing so will not have a meaningful impact on the availability of ICU resources, and because some religious traditions and cultures conscientiously object to the concept of brain death. /cms/asset/5e52562d-3348-483b-b0f3-bb48df30ae6f/mmc1.mp3Loading ... Download .mp3 (43.31 MB) Help with .mp3 files Audio POINT: Should Informed Consent Be Required for Apnea Testing in Patients With Suspected Brain Death? NoCHESTVol. 152Issue 4PreviewPhysicians bear the responsibility to distinguish life from death.1 Identification of irreversible cessation of circulation and breathing or brain function in children and adults, both nationally and internationally, constitutes medical and legal death.1-4 Determination of death by cardiopulmonary criteria is made if a patient has fixed and dilated pupils and no palpable pulse, breath sounds, heart sounds, respiratory effort, or pulsatile arterial blood pressure for 10 minutes.4 Determination of death by neurologic criteria (brain death) requires that a patient be comatose with no brainstem reflexes, and be unable to breathe spontaneously. Full-Text PDF Rebuttal From Drs Truog and TaskerCHESTVol. 152Issue 4PreviewThe answer to the question of whether informed consent should be required before performing apnea testing when determining death by neurological criteria (DNC)1 must be compatible with the relevant ethical and legal principles.2 The notion that "Consent is not required if a procedure is generally recognized by reasonably prudent physicians not to involve a material risk to a patient or in the setting of absence of choice"1 does not, in our view, conform with these principles.2 Full-Text PDF Rebuttal From Drs Lewis and GreerCHESTVol. 152Issue 4PreviewCultural and religious definitions of the exact time of death vary, ranging from the moment that (1) the body becomes pulseless; (2) the skull breaks in a funeral pyre; or (3) the body completely decomposes.1 We agree with Drs Truog and Tasker that "[while we have] no obligation to give deference to minority religious or cultural beliefs and norms, we should not violate them lightly or without just cause."2 The need for uniform criteria for determination of death clearly represents a cause worthy of such a violation, so the Uniform Determination of Death Act was created to legally differentiate the dead from the dying. 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