A Cluster-Randomized Crossover Trial to Compare Spontaneous Breathing Trial With T-piece or Inspiratory Pressure Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,143
- 试验地点
- 6
- 主要终点
- Successful liberation from invasive mechanical ventilation
研究概览
简要总结
Weaning is an important process to gradually separate mechanically ventilated patients from ventilators. A good weaning strategy aims to early identify mechanically ventilated patients who are ready for extubation but not to prematurely extubate them. Spontaneous breathing trial (SBT) is a test to assess the patient's ability to breathe spontaneously when extubated. Several methods have been used to conduct an SBT, including T-piece breathing, low-level pressure support ventilation (PSV) of 5-7 cm H2O, continuous positive airway pressure and automatic tube compensation (ATC).
The investigators hypothesized that an SBT with inspiratory pressure augmentation increases initial SBT success, reduces the length of invasive mechanical ventilation (iMV) support and does not increase reintubation risk as compared with T-piece, which result in a higher proportion of patients successfully liberated from iMV in the inspiratory pressure augmentation group. However, inspiratory pressure augmentation significantly reduces work of breathing on an SBT as compared with T-piece. Patients extubated following an SBT with inspiratory pressure augmentation may experience increased respiratory effort after extubation and this may increase the use of noninvasive ventilation after extubation. An SBT with inspiratory pressure augmentation increases iMV free days but not MV free days as compared with T-piece. Longer iMV free days may be associated with a lower mortality due to fewer iMV related complication.
This study is a pragmatic, cluster-randomized, multiple crossover, multicenter trial to compare SBTs with T-piece versus inspiratory pressure augmentation in weaning outcomes. Mechanically ventilated patients who meet the criteria for readiness to SBT will be included. The patients will use either T-piece or inspiratory pressure augmentation as SBT for weaning according to an ICU-based cluster randomization and crossover sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the adult intensive care unit (ICU)
- •Receiving invasive mechanical ventilation via an endotracheal tube
- •Ready to start an SBT* *The criteria of readiness to an SBT include FiO2 ≤ 0.4, PEEP ≤ 8 cmH2O, minute ventilation ≤ 0.15 L/min/predicted body weight, inspiratory pressure or driving pressure ≤ 14 cm H2O, stable cardiovascular status and no worsening of non-pulmonary organ function.
排除标准
- •Age < 20 years
- •Receiving mechanical ventilation via tracheostomy
- •Mechanical ventilation < 12 hours
- •Invasive ventilation started before the index hospitalization
- •On do-not-intubate order
结局指标
主要结局
Successful liberation from invasive mechanical ventilation
时间窗: ICU discharge, up to 28 days after the initial SBT
The primary study endpoint is to compare the effect of SBT with T-piece versus inspiratory pressure augmentation on the proportion of patients with successful liberation from invasive mechanical ventilation in the ICU among patients who have started an SBT. Successful liberation is defined as sustaining iMV free for at least five days after extubation.
次要结局
- Successful liberation from invasive and noninvasive mechanical ventilation(ICU discharge, up to 28 days after the initial SBT)
- Successful liberation from invasive mechanical ventilation(28 days)
- Use of noninvasive ventilation after extubation(Five days from extubation)
- Time to successful liberation from invasive mechanical ventilation(28 days)
- Time to successful liberation from invasive and noninvasive mechanical ventilation(28 days)
- Initial SBT success(During the ICU stay, up to 28 days)
- Intubation free days(28 days)
- Adjusted risk ratio of successful liberation from invasive mechanical ventilation(ICU discharge, up to 28 days after the initial SBT)
- Extubation failure(Five days from extubation)
- Proportion of planned extubation(ICU discharge, up to 28 days after the initial SBT)
- ICU mortality(ICU discharge, up to 28 days after the initial SBT)
- 28-day mortality(28 days)