跳至主要内容
临床试验/NCT00919971
NCT00919971已完成不适用

Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting

Beaujon Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Correlation between BIS values and RAMSAY score

研究概览

简要总结

To evaluate the effectiveness of use of the bispectral index for monitoring of depth of sedation in ventilated patients during their prehospital management by a physician- staffed EMS. Hypothesis: there is a correlation between BIS and sedation scores.

详细描述

The protocol compares BIS values to the RAMSAY score, which is the validated sedation scoring system in the prehospital setting.Ventilated patients receiving sedatives drugs can be included during primary prehospital interventions or interhospital transfers. During primary prehospital interventions, the protocol starts before endotracheal intubation. Depth of sedation is assessed every 5 minutes by the physician of EMS team. Blinded BIS monitoring is performed at the same time and recorded by the nurse at the end of out-of-hospital management. Data are analysed secondarily by the principal investigator.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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
  • Ventilated patient
  • Exclusion criteria:

排除标准

  • 未提供

结局指标

主要结局

Correlation between BIS values and RAMSAY score

时间窗: Instantaneously

次要结局

  • Correlation between BIS values and ATICE score(Instantaneously)

研究者

发起方
Beaujon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francois-Xavier Duchateau

MD

Beaujon Hospital

研究点 (1)

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