Randomized Trial Comparing Intermittent Sedation and Daily Interruption of Sedation in Mechanically Ventilated Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ventilator free-days
研究概览
简要总结
Sedation is very important in critical care. Critically ill patients are submitted to many stressor factors that have potential to affect longterm outcomes. However, oversedation is associated with increased morbidity, including increased time of mechanical ventilation and ICU stay and longterm psychological complications. Daily interruption of sedation is associated with less time under mechanical ventilation and less posttraumatic stress disorder. Intermittent sedation, when compared with continuous sedation, is also associated with decreased time of mechanical ventilation. The aim of this study is to compare intermittent sedation with daily interruption. Our primary endpoint is free-days of mechanical ventilation in 28 days.
详细描述
A comparison of intermittent sedation - keeping analgesia with fentanyl and midazolam or propofol as boluses if agitation (SAS 5 or more) after adequate analgesia - and daily interruption of sedation - analgesia with fentanyl and sedation wiht midazolam or propofol continuously with daily interruptions every morning until patients awake and can follow simple commands. Sedation is restarted in half previous dosage if agitation (SAS 5 or more) occur.
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
- •Patients under mechanical ventilation with less of 24 hours and a expectative of stay intubated for more than 24 hours
排除标准
- •Intubation secondary to a neurological cause
- •Pregnant women
- •Severe asthma or COPD decompensation
- •Palliative care
研究组 & 干预措施
1. Intermittent sedation
干预措施: Intermittent sedation (Procedure)
2. Daily interruption of sedation
干预措施: Daily interruption of sedation (Procedure)
结局指标
主要结局
Ventilator free-days
时间窗: 28 days
次要结局
- Mortality(28 days)
- Time of stay(ICU, hospitalar)
- Self-extubation(28 days)
- Reintubation(2 days after extubation)
- Incidence of posttraumatic stress disorder(6 months)
- Unplanned withdrawal of catheters(28 days)
研究者
Antonio Paulo Nassar Junior
Antonio Paulo Nassar Junior
University of Sao Paulo General Hospital