Neurologic Physiology After Removal of Therapy (NeuPaRT): Pilot Multicentre Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 5
- 主要终点
- Patient Accrual complete study procedures)
研究概览
简要总结
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.
详细描述
There are many Canadians who need an organ transplant and who will never get one. In the past, people could only be organ donors after being declared brain dead.
The dead donor rule serves this purpose by ensuring that death determination precedes organ retrieval. In Canada, death determination occurs in one of two ways. In neurologic determination of death (NDD), death is declared upon completion of a standardized neurologic assessment that confirms permanent loss of brain activity. In donation after circulatory determination of death (DCDD), death is declared 5 minutes after circulatory arrest. By confirming permanent loss of brain activity, the current NDD process protects donors from suffering and maintains stakeholder trust. In contrast, the current DCDD process assumes, but does not explicitly confirm, permanent loss of brain activity when death is declared 5 minutes after circulatory arrest. While this assumption is rooted in a strong physiologic rationale, lack of compelling evidence regarding cessation of brain activity in humans contributes to ongoing mistrust of the DCDD process among healthcare and public stakeholders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Brain death or plan for Neurologic Determination of Death (NDD)
- •Injuries that anatomically preclude the use of neurologic monitoring
结局指标
主要结局
Patient Accrual complete study procedures)
时间窗: 2022 to 2023
90 patients at all sites and an additional 18 patients at the lead site for specific tests
次要结局
- Waveform Data Completeness(2022-2023)
- Time Difference Circulatory Arrest and Cessation of EEG Activity(2022-2023)
