Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Chongqing Medical University
- 入组人数
- 706
- 试验地点
- 1
- 主要终点
- 28-day intubation-free survival
概览
简要总结
Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.
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
- •Age \>18 years
- •PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315(SpO2 ≤97%)
- •Anticipated NIV duration \> 12 h
- •Preserved consciousness (GCS≥13)
排除标准
- •Use of NIV \> 24 h before randomization
- •Acute-on-chronic respiratory failure
- •Congestive heart failure
- •Use of NIV after extubation (within 48 hours)
- •Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery \[within 7 days\])
- •Pneumothorax
- •NIV intolerance
- •Refusal to participate
- •Pregnancy
- •Need for emergency intubation
研究组 & 干预措施
High PEEP group
Patients in high PEEP group will received 10 to 15 cmH2O of PEEP during noninvasive ventilation.
干预措施: The level of PEEP during noninvasive ventilation (Procedure)
Low PEEP group
Patients in low PEEP group will received 5 cmH2O of PEEP during noninvasive ventilation.
干预措施: The level of PEEP during noninvasive ventilation (Procedure)
结局指标
主要结局
28-day intubation-free survival
时间窗: from randomization to 28 days after randomization
次要结局
- 28-day intubation rate(from randomization to 28 days after randomization)
- the need for intubation within 28 days(from randomization to 28 days after randomization)
- 28-day survival(from randomization to 28 days after randomization)
- 7-category ordinal scale for clinical improvement at 28 days(from randomization to 28 days after randomization)
- 28-day noninvasive ventilator days(from randomization to 28 days after randomization)
- Length of ICU stay(up to 24 weeks)
- 28-day invasive ventilator-free days(from randomization to 28 days after randomization)
- Length of hospital stay(up to 24 weeks)
- ICU mortality(up to 24 weeks)
- Hospital mortality(up to 24 weeks)
- 60-day mortality(from randomization to 60 days after randomization)
研究者
Duan jun
attending physician
First Affiliated Hospital of Chongqing Medical University