Combining Objective and Subjective Sedation Assessment Tools - Second Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 否
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)
