Efficacy of High Flow Oxygen Nasal Cannula Versus Noninvasive Positive Pressure Ventilation After Extubation in Sepsis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Device failure rate
研究概览
简要总结
Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.
详细描述
Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation. The results from recent randomized controlled trials, comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac surgery and high risk patients, showed no significant different in the treatment outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients.
About 40-85% of severe sepsis/septic shock patients developed acute respiratory failure, required endotracheal intubation. According to the nature of patients population, usually eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were considerred as high risk for reintubation, after extubated. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.
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
- •Diagnosis of sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
- •Depended on mechanical ventilator for more than 48 hours
- •Plan for extubation due to successful weaning
排除标准
- •Patient with tracheostomy
- •Recent upper abdominal surgery
- •Wound at face that prohibit face-mask application
- •Patient or 1st degree relative not agree to participate trial
- •Physician prefer either NIV or HFNC for the patient
结局指标
主要结局
Device failure rate
时间窗: an average of 1 year
Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation
次要结局
- 28 day mortality rate(Upto 28 days)
- Hospital mortality rate(an average of 1 year)
- Reintubation rate(an average of 1 year)
研究者
Surat Tongyoo
Associate Professor
Mahidol University