Neurological Determination of Death Adult

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1 Approved by: Vice President and Chief Medical Officer Neurological Determination of Death Adult Corporate Policy & Procedures Manual Number: VII-B-400 Date Approved June 9, 2015 Next Review (3 years from Effective Date) August 2018 Purpose Policy Statement Applicability To ensure a consistent approach is used by Covenant Health physicians when determining neurological determination of death. Covenant Health supports the Canadian guidelines developed for the neurological determination of death. This policy and procedure applies Covenant Health tertiary care facilities and members of the their medical staff. Responsibility The most responsible health practitioner shall demonstrate compliance with this policy by adhering to the requirements outlined herein. Procedure I. Neurological Determination of Death (NDD) (Definition) 1. The absence of clinical brain function when the proximate cause is known and is demonstrably irreversible. All of the following minimum clinical criteria for NDD must be met: 1.1 Established etiology capable of causing neurological death in the absence of reversible conditions capable of mimicking neurological death. 1.2 Deep unresponsive coma. 1.3 Absent brain stem reflexes as defined as absence of gag and cough reflexes and the bilateral absence of the following brainstem reflexes: absent motor responses excluding spinal reflexes absent corneal responses absent papillary responses to light with pupils at mid-position or greater absent vestibule-occular responses. 1.4 Absent respiratory effort based on apnea test. 1.5 Absent confounding factors. 2. The absence of brainstem or cortical cerebral blood flow may be confirmed by ancillary tests, including radionuclide scintigraphy of brain perfusion or intracranial angiogram.

2 VII-B-400 Page 2 of 7 II. PERSONNEL ALLOWED TO DETERMINE NDD 1. NDD shall be determined by at least two fully licensed physicians including neurosurgeons, intensivists and neurologists registered with the College of Physicians and Surgeons of Alberta, or one licensed physician as above in conjunction with a chief neurosurgical resident, possessing an educational license, in the final year of training. 2. Physicians associated with selecting transplant recipients will not participate in the NDD. 3. Physicians who take any part in the NDD process shall not participate in any way in the transplant procedures. 4. Physicians associated with the proposed recipient that might influence the physician s judgement shall not take any part in the NDD process of a potential donor of that recipient. III. CONDITIONS AFFECTING DIAGNOSIS OF NDD 1. Because the clinical diagnosis of NDD cannot be made with certainty on clinical observation alone, the following conditions may interfere with the clinical diagnosis of NDD: Trauma to the eye. Middle or inner ear injuries Cranial neuropathies. Significant cervical spinal cord injury/fracture limiting the ability to perform an oculo-cephalic reflex examination. Severe pulmonary disease. Profound metabolic and endocrine disturbances based on clinical judgement of the physician. Profound glucose, phosphate, calcium and magnesium imbalances based on clinical judgement of the physician. Profound liver or renal dysfunction based on clinical judgement of the physician. Inborn errors of metabolism. Unresuscitated shock. Hypothermia (core temperature less than 34 Celsius. Peripheral nerve or muscle dysfunction or neuromuscular blockade. Clinically significant drug intoxications. 2. Ancillary testing is required when validity of clinical testing is contraindicated. 2.1 In the conditions listed above (#1), the absence of intracranial perfusion demonstrated by radionuclide scintigraphy of brain perfusion or intracranial angiogram is reliable evidence in support of NDD.

3 VII-B-400 Page 3 of Angiography is not recommended as the kidneys may be damaged due to large doses of contrast agents fluid loading and an osmotic diuresis must be induced/maintained to clear the contrast. Please refer to site Radiology protocols to prevent contrast induced nephropathy due to angiography. 2.3 Absence of response on electroencephalogram (EEG) is not a confirmatory test. 2.4 One clinical exam (with or without the inclusion of an apnea test) is required to be performed and documented in the medical record in conjunction with the ancillary test (#2.1 above). 2.5 Caution must be exercised in considering the validity of the apnea test if in the physician s judgement there is a history suggestive of chronic respiratory insufficiency and responsiveness to only supra-normal levels of carbon dioxide (eg. chronic obstructive pulmonary disease), 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 such as radionuclide scintigraphy of brain perfusion should be performed. 2.6 In cases of acute hypoxic-ischemic brain injury, clinical evaluation of NDD should be delayed for 24 hours subsequent to the date/time of resuscitation from the cardio-respiratory arrest. Ancillary test(s) should be performed. 2.7 Results, date and time of ancillary test must be documented on the medical record by the nuclear medicine radiologist. IV. FREQUENCY AND TIMING OF NDD TESTING 1. Two examinations are required for NDD. This ensures that the criteria for NDD are consistent and reduces the possibility of error. 2. A first and second physician s determinations required by the Human Tissue and Organ Donation Act, Alberta, must be performed. Two separate clinical examinations must be completed by two independent physicians to confirm NDD. No fixed interval of time is required between determinations of death. 3. If all criteria for NDD are met, the second declaration is the time that NDD is confirmed. The second declaration will indicate the time of death. 4. The time of interpretation of ancillary tests indicating no brainstem or cortical cerebral perfusion in the absence of clinical criteria confirming NDD will indicate time of death. 5. Observation of a minimum of 24 hours from the date/time of resuscitation from the cardiac arrest is recommended to confirm NDD due to hypoxia/ischemia.

4 VII-B-400 Page 4 of 7 V. CRITERIA FOR NDD 1. All steps listed below are completed by the physician as stated in Personnel Allowed to Determine NDD ) with each NDD clinical examination. 1.1 Cause of coma is known. 1.2 Irreversible etiology for coma has been established. 1.3 Potentially reversible causes of deep coma have been excluded, eg. alcohol or drug intoxication, metabolic impairment, hypothermia (core temperature less than 34 C), shock, and peripheral nerve or muscle dysfunction due to disease or neuromuscular blocking agents. Per point #1 in Conditions Affecting Diagnosis of NDD, the physician determines if significant metabolic impairment is present based on the clinical condition of the patient. 1.4 Absence of any spontaneous or elicited movements (dyskinesias, decorticate or decerebrate posturing or epileptic seizures arising from the brain). Patients with NDD may exhibit various spinal reflex movements, eg. muscle stretch, extensor and/or flexor plantar, abdominal reflex, plantar withdrawal, neck flexion, and hip/arm flexion that should not be misinterpreted as evidence for brain function. 1.5 Absence of brain stem reflexes. Grimacing or other motor response to corneal stimulation or pharyngeal or tracheal suctioning is not compatible with NDD. 1.6 Pupils fixed and dilated bilaterally of at least six millimetre (mm) or larger. 1.7 Absent cough reflex. 1.8 Absence of oculocephalic reflex (Doll s eyes test). This test is not performed on a patient with a suspected spinal cord injury. Eyelids are opened and monitored for tonic movement or nystagmus for two minutes on each side. 1.9 Absence of oculovestibular reflex (Caloric test). This test is performed with a minimum of 120 ml of ice water with the head 30 above horizontal. This test is not performed on a patient with a perforated eardrum Absence of corneal reflex bilaterally Absence of gag reflex Positive apnea test (see Apnea Test below for description of apnea test).

5 VII-B-400 Page 5 of 7 VI. APNEA TEST 1. Patient will have an absence of spontaneous respirations. Patient is apneic when taken off the ventilator for an appropriate time as described in #5 below. 2. To correctly interpret an apnea test, the physician must continuously observe the patient for respiratory effort throughout the performance of the test. The patient s chest is exposed to observe for respiratory effort. If NDD is being determined by two physicians simultaneously, both physicians must be present for the apnea test. 3. Use ancillary test (see point #2 in Conditions Affecting Diagnosis of NDD ) for the following circumstances: 3.1 Patients with a known or suspected history of chronic obstructive pulmonary disease (COPD). 3.2 Patients with previous history of brainstorm lesions including stroke (prior to the current neurological event) should not undergo an apnea test because of their impaired response to carbon dioxide (CO 2 ). 3.3 Patients in whom an adequate assessment of brainstem reflexes cannot be performed (eg. trauma or perforation of the tympanic membrane, significant injury to the cervical spine, drug ingestions). 4. Prerequisites for Apnea Testing 4.1 Prerequisites for apnea testing include: core temperature greater than and equal to 34 C systolic blood pressure (SBP) greater than or equal to 100 mm Hg, mean arterial pressure (MAP) greater than or equal to 70 mm Hg and euvolemia normal partial pressure of carbon dioxide (PaC O 2 ) of approximately 40 mm Hg 4.2 Actions prior to apnea testing Correct to ph greater than or equal to 7.35 with sodium bicarbonate (HCO 3 ) infusion to prevent the development of hypotension during the apnea test. Every effort should be made to replace intravascular volume deficit to maintain systolic blood pressure (SBP) greater than or equal to 100 mm Hg and mean arterial pressure (MAP) greater than or equal to 70 mm Hg with intravenous crystalloid prior to performing the test in order to prevent the development of hypotension. If necessary, utilize vasopressin 0.04 units per minute intravenous (IV) (or other vasopressors/inotropes as specified by a physician).

6 5. Apnea Test Procedure VII-B-400 Page 6 of Before apnea test: Patient core body temperature must be equal to or exceed 34 C. The use of a hyper-hypothermia system may be necessary to raise body temperature by conductive heat transfer. Pre-oxygenation with 100% fraction of inspired oxygen (Fi O 2 ), positive end expiratory pressure (PEEP) = 5-15 centimetres of water (cm H 2 0) for ten minutes. Expose patient s chest to monitor for spontaneous respirations. Patient partial pressure of carbon dioxide (PaCO 2 ) mm Hg During apnea test: Ambu bag/manual ventilation circuit using 100% Fi O 2 at 15 litres/minute (sufficient to inflate the reservoir) and attached to a PEEP valve with PEEP of cm H 2 0. ABG measurement at baseline, three minutes, six minutes, ten minutes, and every 3-5 minutes thereafter. Apnea test is positive if no respirations are observed over the duration of the test, and with the PaCO 2 greater than or equal to 60 mm Hg AND greater than or equal to 20 mm Hg rise above the preapnea test level, AND with a ph less than or equal to These thresholds must be documented by arterial blood gas measurements. If any of the following occur during the apnea test, consideration should be made to discontinue the apnea test: hypotension (SBP less than or equal to 100 mm Hg or MAP less than or equal to 70 mm Hg) hypoxemia with Pa O 2 less than or equal to 60 mm Hg significant arrhythmias 5.3. Post apnea test: Following the apnea test, the patient is manually hyperventilated with 100% oxygen for three minutes prior to resumption of mechanical ventilation. VII. DOCUMENTATION AND FORMS 1. Written documentation of NDD must appear on the patient s chart for all assessments performed. Each assessment must be signed by the physician. Related Documents Covenant Health Policies: Organ and Tissue Donation, #VII-B-415 Death, #VII-B-410

7 VII-B-400 Page 7 of 7 References Chronological Revision Date(s) -JAMC. March 14, 2006, Vol 174, No. 6; (suppl):s1-30. Brain arrest: the neurological determination of death and organ donor management in Canada. Accessed on line December 24, N/A

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