Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Rate of noninvasive ventilation failure
研究概览
简要总结
Current study aimed to explore the effect of high PEEP during noninvasive ventilation among hypoxemic patients with acute respiratory failure.
详细描述
This was a 1:1 randomized control trial to explore the effect of high versus low PEEP in noninvasive ventilation hypoxemic patients with acute respiratory failure. Several ICUs in China performed this study. In the high PEEP group, the PEEP maintained at 10-15 cmH2O, the inspiratory pressure maintained at 15-20 cmH2O. In the low PEEP group, the PEEP maintained at 5 cmH2O, the inspiratory pressure maintained at 10-20 cmH2O. The primary outcome was incidence of noninvasive ventilation failrue.
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
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 16 and 85 years
- •use of dedicated noninvasive ventilator
- •PaCO2 ≤50 mmHg
- •PaO2/FiO2 ≤300mmHg
- •expectation of noninvasive ventilation >12 hours
- •consciousness (Kelly score ≤3 or GCS≥13)
排除标准
- •use of noninvasive ventilation before randomization > 24 hours
- •use of noninvasive ventilation due to heart failure, asthma, acute excerbation of COPD
- •presence of contraindication of noninvasive ventilation such as malformation, rencent pulmonary or esophageal surgery et al.
- •end stage disease (expectation of life < 6 months)
- •pneumothorax
- •noninvasive ventilation intolerance
- •refusal of paticipation
- •pregant woman
- •requirement of emergency intubation
结局指标
主要结局
Rate of noninvasive ventilation failure
时间窗: From randomization to 28 days of study
Noninvasive ventilation failure was defined as intubation, death or withdrawal of therapy during noninvasive ventilation.
次要结局
- 28-day mortality(From randomization to 28 days of study)
- Length of stay in ICU(From beginning to 28 days of study)
- The changes of PaO2/FiO2(From randomization to 28 days of study)
- Duration of invasive mechanical ventilation(From randomization to 28 days of study)
- Duration of noninvasive ventilation(From beginning to 28 days of study)
- Length of stay in hospital(From beginning to 28 days of study)
- Side effect(From randomization to 28 days of study)
研究者
Duan jun
Principal Investigator
Chongqing Medical University