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临床试验/NCT03575169
NCT03575169已完成不适用

The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

University of Aberdeen4 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
4
主要终点
Mean BIS for Population Over 24 Hours

研究概览

简要总结

An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

详细描述

Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.

All clinical care is at the discretion of the clinical team.

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

  • •Adults (over 18)
  • •Diagnosis of traumatic brain injury
  • •Expected to survive
  • •Expected to require greater than 24 hours of sedation and mechanical ventilation

排除标准

  • •Brain injury thought to be unsurvivable by ICU clinical team
  • •Frontal decompressive craniectomy
  • •Use of ketamine infusion at recruitment or planned use within 24 hours
  • •Fractured frontal bone or severe overlying soft tissue injury
  • •Simple extradural haemorrhage with no other obvious intracranial injury
  • •Pregnant patient

研究组 & 干预措施

Patients with TBI

Admitted to Aberdeen ICU with diagnosis of TBI and expected to require greater than 24 hours sedation.

干预措施: BIS Monitor (Device)

结局指标

主要结局

Mean BIS for Population Over 24 Hours

时间窗: 24 hours

Mean BIS of patients sedated. BIS is a processed EEG value ranging from 0 to 100, with lower values representing decreased brain activity. The usual range for General Anaesthesia is 40-60.

次要结局

  • Mean ICP for Population Over 24 Hours(24 hours)
  • Incidence of Osmotherapy Use for Population Over 24 Hours(24 hours)
  • Median Vasopressor Dose for Population Over 24 Hours(24 hours)
  • Sedative Dose for Population Over 24 Hours(24 hours)
  • Length of ICU Stay for Population Over 24 Hours(Days to weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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