CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 407
- 试验地点
- 2
- 主要终点
- rate of re-intubation
研究概览
简要总结
The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
详细描述
We want to test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
Primary end point: to reduce the rate of re-intubation.
Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.
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 undergoing cardiac surgery on cardiopulmonary bypass
- •PaO2 /FiO2 < 200 after extubation
- •extubation time < 24 h.
排除标准
- •patients < 18 years old
- •extracorporeal membrane oxygenation
- •severe cardiac dysfunction (FE<25%)
- •mechanical ventilation before the intervention
- •severe COPD (patients on oxygen therapy, with a FEV1< 50%)
- •heart or lung transplantation
- •lack of consent.
研究组 & 干预措施
CONTROL
Venturi Mask
干预措施: Venturi Mask (Procedure)
TREATMENT
Helmet CPAP
干预措施: Helmet CPAP (Procedure)
结局指标
主要结局
rate of re-intubation
时间窗: at 28 days
次要结局
- incidence of atelectasis(at 28 days)
- incidence of pneumonia(at 28 days)
- incidence of sepsis(at 28 days)
- the intensive care unit length of stay(at 28 days)
- mortality rate(at 28 days)
- hospital length of stay(at 28 days)
研究者
Daniela Pasero
Principal Investigator
University of Turin, Italy