Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
研究概览
简要总结
Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method.
Objectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.
详细描述
During the inclusion period (at least 10 min and maximum 30 min), the patients ware a high FiO2 mask, driven by 10-15L/min oxygen and are randomly assigned to control or NIV group. Preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. For the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15L/min oxygen. Patients allow to breath spontaneously with occasional assists (usual preoxygenation method). For the NIV group, pressure support mode is delivered by an ICU ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 mL/kg. The fraction of inspired oxygen (FiO2) was 100% and we used a PEEP level of 5 cmH2O.
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
- •Adults patients with acute respiratory failure requiring intubation
排除标准
- •Encephalopathy or coma, cardiac resuscitation
结局指标
主要结局
The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
时间窗: the first week
次要结局
- The mean drop in SpO2 during endotracheal intubation.(during the intubation)
- Mortality(in reanimation)
- Number of organ failures (SOFA score >2)(during the 7 days after intubation)
- ICU length of stay(during the stay in reanimation)