Neurologic Physiology after Removal of Therapy: study details
| Study detail | |
| Background | In controlled organ donation after circulatory determination of death (cDCDD), permanent loss of brain activity is assumed (but not confirmed) to occur within the hands-off period following circulatory arrest, after which organ retrieval surgery commences. Lack of confirmatory human data to support this assumption contributes to anxiety around cDCDD protocol. |
| Aim | Provide data to inform the timing of death determination in cDCDD by documenting the temporal relationship between the cessation of neurological and circulatory activities after WLSM in the ICU. |
| Study population | Adult patients undergoing planned WLSM in participating ICUs with the expectation that death will ensue within 24 hours. This population is representative of the relevant cDCDD donor population. |
| Design | Prospective observational multicentre pilot feasibility study carried out over 3 years at five academic centres in Canada. n=80. |
| Data collection instruments | Routine clinical monitors: arterial pulse pressure, cardiac electrical activity and oxygen saturation using standard clinical monitors. Non-therapeutic monitors: cortical electrical activity using v-EEG; cerebral blood flow using TCD; brainstem function using BAEPs; cortical function using SSEPs. Two of four non-therapeutic procedures on any given patient. |
| Data collection process | Recording spanning 30 min prior to WLSM and up to 30 min following circulatory arrest. |
| Data analysis | Using synchronised waveform data from each patient, we will establish the time of cessation of brain activity relative to circulatory arrest. |
| Outcome measures | Time of cessation of brain activity measured using non-therapeutic monitors, time of circulatory arrest. |
BAEP, brainstem auditory evoked potential; ICU, intensive care unit; SSEP, somatosensory evoked potential; TCD, transcranial Doppler; v-EEG, video electroencephalogram; WLSM, withdrawal of life-sustaining measures.