One-Hour Positive Pressure Ventilation After a Pressure Support Spontaneous Breathing Trial: A Randomized Clinical Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 4,000
- 主要终点
- Number of Participants With Extubation Failure Within 7 Days
概览
简要总结
This is a randomized, open, multicenter, pragmatic, adaptive clinical trial with intention-to-treat analysis. The study will compare two weaning strategies from mechanical ventilation in critically ill patients admitted to intensive care units, with more than 72 hours of mechanical ventilation and with a successful spontaneous breathing trial on pressure support. Immediately after a successful spontaneous breathing trial, eligible patients will be randomized into 2 groups that will be treated according to one of the following interventions:1) One-hour positive pressure ventilation: as soon as the success of the spontaneous breathing trial is confirmed, the patient is submitted to mechanical ventilation for 1 hour using the previous ventilatory parameters and, afterwards, extubated.2) Immediate extubation: the patient is extubated immediately after the success of the spontaneous breathing trial.
详细描述
Adaptive design for sample size. The study will include up to a maximum of 4.000 patients. First interim analysis will be performed after complete data is available for the first 500 eligible patients. The Bayesian logistic regression model will be adjusted to provide posterior probabilities that will be compared with threshold values to evaluate stopping decisions. Extensive simulations were conducted to develop and understand adaptive design performance, interim analysis timing, and decision criteria. The trial may be stopped early for efficacy or futility. Secondary outcomes will be analyzed with a gatekeeping procedure to preserve overall type I error at 0.05. Thus, the assessment of statistical significance of secondary outcomes will be performed only if the preceding outcome in the hierarchy met the threshold for statistical significance. No adjustment for multiple comparisons will be applied for analyses of tertiary outcomes and subgroups. Thus, these results should be interpreted as exploratory.Secondary outcomes tested in hierarchical order will be: (1) Mechanical ventilation free days within 28 days; (2) Hospital free days within 28 days; (3) Mortality within 28 days.
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
- •Patients aged \> 18 years.
- •Admitted to the intensive care unit (surgical or medical).
- •With endotracheal intubation.
- •Mechanical ventilation for more than 72 hours.
- •Who underwent successful spontaneous breathing trial (according to the study protocol) and is considered able to be extubated.
排除标准
- •Patients unable to obey commands.
- •With non-planned extubation.
- •Neuromuscular disease and cervical spinal cord injury.
- •Tracheostomy.
- •Contraindication for cardiopulmonary resuscitation or reintubation.
- •Terminal extubation.
- •Lack of informed consent.
- •Previously included in the trial.
研究组 & 干预措施
One-hour positive pressure ventilation
干预措施: One-hour positive pressure ventilation (Other)
Immediate extubation
干预措施: Immediate extubation (Other)
结局指标
主要结局
Number of Participants With Extubation Failure Within 7 Days
时间窗: 7 days (from randomization through Day 7 after randomization)
Extubation failure is defined as a composite endpoint of reintubation or death within 7 days after randomization
次要结局
- Ventilator-Free Days Through Day 28(28 days (from randomization through Day 28 after randomization))
- Hospital-Free Days Through Day 28(28 days (from randomization through Day 28 after randomization))
- Number of Participants Who Died Within 28 Days(28 days (from randomization through Day 28 after randomization))