Neurologic Physiology After Removal of Therapy (NeuPaRT)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

The purpose of this study is to determine when brain function stops compared to when the heart stops by monitoring electrical brain activity in patients who are taken off life support and progress to death in the intensive care unit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Plan for the withdrawal of life sustaining measures (WLSM)

Attending physician anticipates patient will die within 24 hours of the withdrawal of life sustaining measures

Patient has an indwelling arterial cannula for monitoring blood pressure

Disqualifiers

Brain death or plan for Neurologic Determination of Death (NDD)

Injuries that anatomically preclude the use of neurologic monitoring

Trial population

The study will include all patients admitted to a participating ICU who fulfil all the inclusion criteria and for whom none of the exclusion criteria exist.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • electroencephalography (EEG)

    Diagnostic test

    1. brain cortical activity using full scalp 2. cerebral blood flow velocity 3. during the dying process following planned withdrawal of life sustaining measures (WLSM)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Patient Accrual complete study procedures)

90 patients at all sites and an additional 18 patients at the lead site for specific tests

Time frame
2022 to 2023

Secondary outcomes

1

Waveform Data Completeness

Adequate waveform signal that (i) spans circulatory arrest, (ii) includes data for at least 80% of the planned observation period (from the withdrawal of life sustaining measures to 30 minutes after circulatory arrest \[or 5 minutes for confirmed donation after circulatory determination of death (DCDD) donors\]), and (iii) has a clearly identifiable time of cessation for each signal.

Time frame
2022-2023
2

Time Difference Circulatory Arrest and Cessation of EEG Activity

Cerebral blood flow velocity in middle cerebral artery (when available), and cessation of event/evoked potentials (LHSC site only). See below for definition of cessation of each signal.

Time frame
2022-2023

Other outcomes

Sponsors and contacts

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