Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,180
- 试验地点
- 86
- 主要终点
- Day-90 mortality
研究概览
简要总结
The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.
详细描述
In intensive care unit (ICU) patients receiving mechanical ventilation (MV), potent hypnotics and morphinics are frequently administered to increase synchrony with the ventilator, control agitation and decrease discomfort and pain due to the tracheal tube, bed ridding, painful condition and diagnostic or therapeutic procedures.
However, administration sedatives or morphinics is often excessive and may result in deep and prolonged alteration of consciousness, delayed weaning from MV and prolonged MV. and exposes the patient to a higher risk of ventilator-associated pneumonia, ICU delirium and neuromuscular weakness at awakening.
The present randomized multicenter study will compare the day-90 mortality of a group of patients receiving conventional sedation to the mortality of a group of patients receiving sedation administered according to an algorithm aimed to prevent oversedation to the mortality. The algorithm is built on a graduate therapeutic response to increasingly intense symptoms of discomfort, pain, ventilator dyssynchrony and agitation, and includes the use of analgesics, non hypnotic benzodiazepines, neuroleptics, repeated intravenous (IV) boluses of hypnotics and short duration (6 hours) IV hypnotic infusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age 18 and older
- •Admission to ICU with expected mechanical ventilation duration > 48 hrs
- •Mechanical ventilation in ICU for less than 12 hours
- •Information provided to the patient or proxy
排除标准
- •ICU Admission after cardiac arrest
- •Acute or chronic neuromuscular disease
- •Tracheotomy on ICU admission
- •Acute cerebral injury with intracranial hypertension requiring continuous IV sedation with or without neuromuscular blockade
- •Status epilepticus
- •Treatment withdrawal decision
- •Pregnancy, breast feeding
- •Concurrent participation in another interventional study requiring a change in usual practice of sedation or mechanical ventilation
结局指标
主要结局
Day-90 mortality
时间窗: Mortality at Day 90 after randomization
次要结局
- Hospital mortality(at hospital discharge, up to day 90)
- Number of patients requiring tracheotomy(During ICU stay, up to day 28)
- First sitting in chair(During ICU stay, up to day 28)
- Mortality at Day 28(at day 28)
- 1-yr mortality(at 1 yr)
- Mechanical ventilation duration(From onset of mechanical ventilation to day 28)
- Days alive with no mechanical ventilation(From ICU admission up to day 28)
- Occurence of ventilator-associated pneumonia(During mechanical ventilation duration, up to day 28)
- Use of non-invasive ventilation after extubation(From extubation to ICU discharge up to day 28)
- Duration of ICU stay(From ICU admission to ICU discharge or death in ICU, up to day 90)
- ICU confusion(From Day 1 to 7, and at day 14, 21 and 28)
- Proximal muscle weakness(from day 1 to 7, and at day 14, 21 and 28)
- Functional, cognitive and psychological status(At day 90 and 1 year)
- Time to weaning onset(Time from mechancial ventilation initiation to first spontaneous breathing trial, up to day 28)