Evaluation of an Oxygenation and Ventilation Support Protocol for the PREvenTion of EXTubation Failure: a Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,100
- 主要终点
- Rate of reintubation
研究概览
简要总结
Reintubation after failed extubation would be associated with increased mortality. Therefore, extubation failure remains a major concern in ICU. Few randomized controlled studies have assessed the benefit for a systematic respiratory support (noninvasive ventilation or high flow nasal cannula) applied at the time of extubation to reduce reintubation rates in patients at high and low risk for reintubation. In addition, these studies reported discordant results. Therefore, there are some concerns regarding effectiveness and systematic uptake of a respiratory support after extubation into usual practice.
详细描述
The aim of this trial is to determine whether a protocolized postextubation respiratory support including High-flow Nasal Oxygen (HFNO) and Noninvasive Ventilation (NIV) could reduce the rate of reintubation in comparison with usual practice. Therefore, all consecutively eligible patients for the study, will be assigned to a protocol arm in accordance with the randomized period
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Adult patients
- •Intubated more than 24 hours in the ICU
- •Ready for a scheduled extubation then extubated
排除标准
- •Contraindication to HFNO or NIV
- •Underlying chronic neuromuscular disease
- •Unplanned extubation (accidental or self-extubation)
- •With a do-not-reintubate order at time of extubation
- •Tracheotomia
研究组 & 干预措施
control period
the control period corresponds to usual care of centers
protocolized period
the protocolized period corresponds to a protocolized use of HFNO or NIV after extubation
干预措施: protocolized postextubation support (Procedure)
结局指标
主要结局
Rate of reintubation
时间窗: 7 days following extubation
Reintubation following extubation
次要结局
未报告次要终点