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临床试验/NCT04506788
NCT04506788已完成不适用

Assessment of EEG Slow Wave Activity in Comatose Cardiac Arrest Survivors Under Propofol Anesthesia

University of Oulu1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
EEG slow wave activity

研究概览

简要总结

BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome.

详细描述

BrainICU is a prospective observational study investigating the EEG slow wave activity in comatose cardiac arrest survivors under propofol anesthesia and its association with neurological outcome. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially the EEG are excluded. The patients' relatives are asked for an informed written consent to participate. In the intensive care, the patients are sedated using continuous infusion of propofol while receiving temperature management/hypothermia treatment following the ICUs' common practice. EEG is recorded within the first 24h after ICU admission. If possible, the recording is repeated on the second and third day i.e. 48h and 72h after ICU admission, respectively. To induce the maximum effect of propofol on EEG, additional boluses of propofol during the EEG recording may be given until the burst suppression level is reached. Slow wave activity is calculated offline from the EEG recordings. The neurological recovery of the patients is defined 6 months after cardiac arrest from patient documents and/or by phone call to the patient/ relative using Cerebral Performance Category. After the follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate the health and quality of life.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Comatose patients admitted to intensive care after cardiac arrest

排除标准

  • Previous neurological disease expected to affect EEG substantially

结局指标

主要结局

EEG slow wave activity

时间窗: 0-72 hours

EEG slow-wave activity determined from the low-frequency (\<1 Hz) signal component calculated from the EEG recordings made within 24 hours from ICU admission and repeated, if possible, at 48 hours and 72 hours.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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