Table 1

Neurologic Physiology after Removal of Therapy: study details

Study detail
BackgroundIn 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.
AimProvide 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 populationAdult 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.
DesignProspective observational multicentre pilot feasibility study carried out over 3 years at five academic centres in Canada. n=80.
Data collection instrumentsRoutine 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 processRecording spanning 30 min prior to WLSM and up to 30 min following circulatory arrest.
Data analysisUsing synchronised waveform data from each patient, we will establish the time of cessation of brain activity relative to circulatory arrest.
Outcome measuresTime 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.