Appendices to Adverse events during apnea testing for the determination of death by neurologic criteria: A single center, retrospective pediatric cohort
Table of Contents
Appendix 1: Determination of Death by Neurologic Criteria (aka Brain Death) Clinical Practices Policy, pages 2-5
Appendix 2: Revisions to the Determination of Death by Neurologic Criteria Clinical Practices Policy, page 6
Policy
CCHMC Clinical Practices Policy
Policy Number CPC-I-108 Effective Date 11/10/2017Determination of Death by Neurologic Criteria (aka Brain Death)
Page 1 of 41.0 PURPOSE
To outline guidelines for the determination of death by neurologic criteria in term newborns (37 weeks gestational age), infants, children and patients greater than 18 years of age.
2.0 POLICY
2.1.A neurologic evaluation to determine death will be performed on all patients suspected of fulfilling the neurologic criteria for death and meeting the prerequisites listed under 4.2 unless the parent(s), next of kin, or legal guardian makes a decision to withdraw life-sustaining treatment. When the prerequisites for neurologic evaluation are fulfilled, specific informed consent is not required.
2.2.The diagnosis of death by neurologic criteria should be made by physicians with specific training and/or experience in this area.
2.3.The diagnosis should be made by physicians who have evaluated the history and completed neurologic examinations to confirm the coexistence of a known irreversible cause of coma and the absence of brainstem function including apnea.
2.4.When appropriate, the parent(s), next of kin, or legal guardian should be offered the opportunity to be present during the neurologic evaluation.
2.5.A patient with confirmed death by neurologic criteria pursuant to accepted medical standards is deceased under Ohio law. Ohio Rev. Code § 2108.30.
2.6.Once death is declared, all medical interventions will be discontinued and removed in an appropriate period of time.
2.7.It is essential to communicate with the parent(s), next of kin, or legal guardian regarding the suspicion the patient has died, the criteria and tests for death, and the removal of medical interventions once death is confirmed. All conversations with the parent(s), next of kin, or legal guardian about these issues should be clearly summarized in the medical record. The parent(s), next of kin, or legal guardian should be given appropriate time to understand the information before completing the neurologic evaluation.
3.0 DEFINITIONS
N/A4.0 IMPLEMENTATION
4.1.Neurology consultation should be strongly considered for all patients with acute brain injury.
4.2.Prerequisites for initiating neurologic evaluation to confirm a patient has died:
4.2.1.An irreversible cause of coma is identified and coma and apnea must coexist.
4.2.2.Hypotension, hypothermia, and metabolic disturbances that could affect the neurologic evaluation must be corrected before the evaluation.
4.2.2.1.Core body temperature is over 35°C (95°F)
4.2.2.2.Systolic blood pressure or mean arterial pressure in acceptable range for age 4.2.2.3.Plasma sodium level no greater than 160
4.2.3.Sedatives, analgesics, neuromuscular blockers, and anticonvulsant agents should be
discontinued for a reasonable time period based on elimination half-life of the drug to ensure they do not affect the neurologic evaluations to determine death by neurologic criteria. Blood or plasma levels to confirm that high or supra-therapeutic levels of such drugs are not present should be obtained if readily available and repeated as needed or until the levels are in the low to mid- therapeutic range.
4.2.4.The diagnosis of death based on neurologic evaluation alone should not be made if supra-
Policy
CCHMC Clinical Practices Policy
Policy Number CPC-I-108 Effective Date 11/10/2017Determination of Death by Neurologic Criteria (aka Brain Death)
Page 2 of 4or mid-therapeutic range, medication effects sufficient to affect the results of the neurologic evaluation are unlikely. If uncertainty remains, an ancillary study should be performed.
4.2.5.Assessment of neurologic function may be unreliable immediately after cardiopulmonary resuscitation or other severe acute brain injuries and neurologic evaluation should be deferred for 24–48 hours if there are concerns or inconsistencies in the evaluation.
4.3.Number of evaluations, evaluators, and observation periods
4.3.1.Two evaluations as outlined below, separated by an observation period, are required. The evaluations should be performed by different attending physicians or their designees under their direct supervision involved in the care of the patient. The apnea test portions of the evaluations may be performed by the same physician.
4.3.1.1.Recommended observation periods between evaluations: Term infants ≥ 37 weeks gestation up to 30 days of age: 24 hours. Patients >30 days of age, including adult patients: 12 hours 4.3.1.2.The first evaluation determines the patient has met the neurologic criteria for death. The
second evaluation confirms that the patient has fulfilled the neurologic criteria for death.
4.3.2. Neurologic evaluation:
4.3.2.1.The patient must exhibit complete loss of consciousness, vocalization, and volitional activity, lack all evidence of responsiveness, including eye opening or eye movement to noxious stimuli. Noxious (deep, painful) stimuli should not produce a motor response other than spinally mediated reflexes.
4.3.2.2.Loss of all brain stem reflexes:
Midsize or fully dilated, fixed pupils which do not respond to light.
Absence of movement of bulbar musculature including facial and oropharyngeal muscles.
Deep pressure on the condyles at the level of the temporomandibular joints and deep pressure at the supraorbital ridge should produce no grimacing or facial muscle movement.
Absent gag and cough reflexes
Absent sucking and rooting reflexes (neonates and infants)
Absent corneal reflexes.
Absent oculovestibular (cold caloric) reflexes, tested by irrigating each ear with ice water after the patency of the external auditory canal is confirmed. The head is elevated to 30°. Each external auditory canal is irrigated (one ear at a time) with approximately 50 mL of ice water. Movement of the eyes should be absent during 1 minute of observation. Both sides are tested with an interval of several minutes between them.
Flaccid tone and absence of spontaneous or induced movements, excluding spinal cord events such as reflex withdrawal or spinal myoclonus.
Apnea.
4.3.2.3.Apnea testing:
4.3.2.3.1.Apnea testing must be performed using accepted testing methods and requires documentation of an arterial PaCO2 20 mmHg above the baseline PaCO2 and ≥ 60 mmHg with no respiratory effort during the testing period to support the diagnosis of death.
Note: in cases where the patient does not have arterial access, venous samples are acceptable with the following adjustments: target PCO2 20mmHg above baseline and ≥ 70 mmHg; frequent cycling of non-invasive blood pressure measurements during the apnea test.
Policy
CCHMC Clinical Practices Policy
Policy Number CPC-I-108 Effective Date 11/10/2017Determination of Death by Neurologic Criteria (aka Brain Death)
Page 3 of 44.3.2.3.2.If the apnea test cannot be performed as a result of a medical contraindication or cannot be completed because of hemodynamic instability, desaturation to < 85%, or an inability to achieve specified PaCO2 parameters, an ancillary study should be performed.
4.3.2.3.3.Evidence of any respiratory effort is inconsistent with death and the apnea test should be terminated.
4.3.3.Ancillary studies:
4.3.3.1.Ancillary studies (death protocol-electroencephalography and radionuclide cerebral blood flow) are not required to establish death unless all other components of the neurologic evaluation (4.4.1, 4.4.2, 4.4.3) cannot be completed.
4.3.3.2.Ancillary studies are not a substitute for any of the other components of the neurologic evaluation.
4.3.3.3.For all age groups, ancillary studies can be used to assist the clinician in making the diagnosis of death to reduce the observation period. When an ancillary study is used to reduce the observation period, all o t h e r components of the neurologic evaluations should be completed and documented.
4.3.3.4.If the ancillary study supports the diagnosis, the second evaluation can then be performed. If the ancillary study is equivocal or if there is concern about the validity of the ancillary study, the patient cannot be pronounced dead. The patient should continue to be observed until death can be declared on neurologic evaluation criteria or a follow-up ancillary study can be performed to assist with the determination of death. A waiting period of 24 hours is
recommended before further clinical re-evaluation or repeat ancillary study is performed.
Supportive patient care should continue during this time period.
4.4.Declaration of death:
4.4.1.Death shall be immediately declared after confirmation and completion of the second neurologic evaluation.
4.4.2.When ancillary studies are used, documentation of components from the neurologic evaluations that can be completed must remain consistent with death across evaluations. Death is declared at the completion of the final component or study.
4.4.3.Findings of the neurologic evaluation components, and any ancillary studies should be documented in the medical record.
4.5.Removal of medical interventions:
4.5.1.Once death is declared, all medical interventions will be discontinued and removed in an appropriate period of time.
4.6.Special cases: For the following special cases, evaluation for the determination of death using neurologic criteria may proceed as above with the following recommendations enlisted for the apnea test portion of the evaluation.
4.6.1.Cyanotic congenital heart disease patients. For patients with baseline oxygen saturations > 85%, the apnea test may be performed and should be terminated if the saturation falls below 85%.
Patients with baseline saturations less than 85% may undergo apnea testing at the discretion of the attending physician with the threshold for termination determined a priori by the primary physician (e.g. some percentage below baseline). In any instance, an ancillary study may be performed in addition to apnea testing or in lieu of apnea testing.
4.6.2.Patients supported with Extra-Corporeal Membrane Oxygenation (ECMO); modifications to the apnea test to achieve the goal rise in PaCO2:
Policy
CCHMC Clinical Practices Policy
Policy Number CPC-I-108 Effective Date 11/10/2017Determination of Death by Neurologic Criteria (aka Brain Death)
Page 4 of 41. Decrease sweep gas to oxygenator to 0.1 liters per minute (LPM). Monitor patient for
respiratory effort and the in-line blood gas monitor (CDI) for increasing PaCO2. Once PaCO2 is 20 mmHg above baseline and ≥60 mmHg per CDI, draw a patient arterial blood gas (ABG).
If the PaCO2 goal is achieved and if the patient has not exhibited any respiratory effort, the apnea test is consistent with death and can be completed with the patient returned to
supportive care pending any remaining testing. If the PaCO2 is not within the desired range, progress to number 2.
2. Turn sweep gas to oxygenator off completely. Monitor patient for respiratory effort and CDI for increasing PaCO2. Once PaCO2 is 20 mmHg above baseline and ≥60 mmHg per CDI, draw a patient ABG. If the PaCO2 goal is achieved and if the patient has not exhibited any respiratory effort, the apnea test is consistent with death and can be completed with the patient returned to supportive care pending any remaining testing. If the PaCO2 is not within the desired range, progress to number 3.
3. Turn sweep gas to oxygenator back on to 0.1 LPM and bleed in CO2, starting with 20 ml/min and increasing as needed to achieve a PaCO2 20 mmHg above the baseline and ≥60 mmHg by CDI and patient ABG. Once the PaCO2 is increasing, observe for any respiratory effort until the goal PaCO2 is reached. Once the PaCO2 goal is achieved and if the patient has not exhibited any respiratory effort, the apnea test is consistent with death and can be completed with the patient returned to supportive care pending any remaining testing.
For patients who are likely to have significant oxygen desaturation with lower gas flows leading to termination of the apnea test, gas flows may be maintained to ensure adequate oxygenation and then CO2 can be bled into the circuit as above.
4.7.If unable to perform the apnea test because of desaturation or an inability to reach a PaCO2 ≥60 mmHg and 20 mmHg above baseline, then an ancillary study, preferably EEG, should be performed. If a
nuclear flow study performed, the radio-isotope will be instilled by the ECMO specialist post-membrane.
5.0 OVERSIGHT
All revisions of this policy must be approved by the responsible department before being approved by the Clinical Practices Committee. This policy will be reviewed every three years or sooner if deemed
necessary. Policy authority for this document resides with the Clinical Practices Committee.
6.0 REFERENCES
N/A
R
EVISIONH
ISTORY Original Date2/1/1985 Revision Date
6/11/2010; 5/11/2012; 2/14/2014, 08/12/2016, 11/10/2017 Review Date