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临床试验/NCT00734409
NCT00734409已完成不适用

Combining Objective and Subjective Sedation Assessment Tools - Second Study

Duke University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2008年5月1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
300
试验地点
2
主要终点
Mean Sedative Use

研究概览

简要总结

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.

详细描述

Patients in the intensive care unit (ICU) who require a ventilator to help them breathe also require sedation in order to keep them comfortable and prevent injury. The national guidelines for sedation management include a daily interruption of sedation performed once each morning. To determine the amount of sedation needed, the current standard practice is to use a system called the Richmond Agitation-Sedation Scale (RASS). The patient is stimulated by calling their name or by tapping their shoulder until the patient's responses indicate that a satisfactory level of sedation has been achieved.

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the RASS will give better assessment of a subject's level of sedation. The BIS monitor is a sensor strip taped to the forehead and attached to a device that reads electrical activity from the brain. It is approved by the U.S. Food and Drug Administration (FDA) for monitoring patients under sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • patient in the ICU
  • continuous IV sedation with propofol midazolam or dexmedetomidine
  • age > 18
  • expected to require mechanical ventilation for >=48 hours

排除标准

  • prisoners
  • no available space on forehead
  • continuous electroencephalography(EEG) monitoring
  • bifrontal brain injury
  • barbiturate coma therapy
  • known hypersensitivity to study medications
  • high risk for ethanol (ETOH) withdrawal
  • resuscitation from cardiac arrest without recovery of mental status
  • moribund clinical state (death expected within 48 hours)

结局指标

主要结局

Mean Sedative Use

时间窗: Intensive Care Unit (ICU) stay through discharge

The mean amount of propofol used on each patient while the patient was in the ICU and receiving mechanical ventilation.

次要结局

  • Unplanned Self-device Removal Events(ICU stay through discharge)
  • Mean Days on Mechanical Ventilation(ICU stay- through discharge)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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