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临床试验/NCT03287401
NCT03287401已完成不适用

Prediction of Postoperative Anesthesia Care Unit Delirium Using Electroencephalography - German Validation Study

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
PACU Delirium

研究概览

简要总结

Aim of this observational study is to investigate whether frontal electroencephalogram analysis is able to predict increased risk for PACU delirium.

详细描述

Delirium in the postoperative anaesthesia care unit (PACU), a special of form of postoperative delirium, is associated with increased hospital stay and an elevated hospital re-admission rate. First studies investigating the patients' electroencephalogram (EEG) on emergence from anaesthesia were able to show that an abrupt change of predominant EEG-rhythm is associated with an increased rate of PACU delirium. Therefore, it seems possible to use frontal EEG in order to identify patients being at elevated risk for PACU delirium.

Aim of this observational study is to validate the results of an international collaboration in a German population of patients undergoing general anaesthesia. EEG in these patients is recorded from start of anaesthesia until emergence. Rate of PACU delirium is assessed using the CAM-ICU score 15 and 60 minutes after emergence in the recovery room.

In a pilot study in 626 patients from 2013 to 2015 in 5 international study centres the rate of PACU delirium was 20%. As it is planned to investigate 5 co-factors using regression analysis 50 cases of delirium will be necessary for a sufficient analysis. Therefore, in total 250 patients will be included.

Due to an additional study centre that included 50 patients enrolment of the german validation group was completed after 200 patients.

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

入选标准

  • age: 18 years or older
  • surgery in general anaesthesia

排除标准

  • emergency surgery
  • general anaesthesia within 30 days before

结局指标

主要结局

PACU Delirium

时间窗: Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes)

Detection of delirium in the postoperative anaesthesia care unit using CAM-ICU score

次要结局

  • Electroencephalography(Pre-induction until emergence from anaesthesia (average of 3 hours))
  • Pain in the PACU (NRS)(Emergence from anaesthesia until discharge from postoperative anaesthesia care unit (60 minutes))

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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