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临床试验/NCT03485781
NCT03485781已完成不适用

Assessment of Hypoxic Brain Injury by Analyzing Propofol-induced EEG Changes

University of Oulu2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2017年10月12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
102
试验地点
2
主要终点
EEG slow-wave activity

研究概览

简要总结

PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest.

详细描述

PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially 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 continuously from the admission to the ICU until 48 hours from the cardiac arrest. EEG slow-wave activity is determined offline by calculating the low-frequency (<1 Hz) power from the signal. 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: 0-48 hours

EEG slow-wave activity defined by the low-frequency (\<1 Hz) signal power calculated continuously from the beginning of EEG measurement until 48 hours from cardiac arrest. The study investigates the association between the slow-wave activity and neurological outcome i.e. Cerebral Performance Category after 6 month follow-up period.

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 (2)

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