Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- FeO2 at 3 min
研究概览
简要总结
High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. However, its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement during preoxygenation before general anaesthesia.
The goal of the present study is to measure end tidal oxygen after 3 min of preoxygenation using the recommended method (spontaneous breathing of 100% inhaled oxygen through a face mask) and using high flow nasal canula oxygen, in healthy volunteers.
详细描述
High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. The results suggest that high flow oxygen could be superior to bag reservoir face mask in term of occurrence of severe hypoxemia during the intubation procedure.
At the present time its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement ensuring that the functional residual capacity has been filled with oxygen.
We planned a randomised cross over study in healthy volunteers studying efficacy and tolerance of preoxygenation using spontaneous ventilation with 100% inhaled oxygen through a face mask connected to the anaesthesia machine and preoxygenation using high flow nasal cannula oxygen (60l/min).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •healthy volunteers,
- •signed contentment
排除标准
- •any chronic or acute disease,
- •pregnancy
研究组 & 干预措施
control
spontaneous breathing through a face mask connected to the anaesthesia machine delivering 100% oxygen gas flow (15l/min)
干预措施: preoxygenation (Procedure)
ohd
spontaneous breathing through a nasal cannula connected to an humidifier device delivering warm (37°C) high flow oxygen(60l/min)
干预措施: preoxygenation (Procedure)
结局指标
主要结局
FeO2 at 3 min
时间窗: 3 minutes
end tidal oxygen fraction measured through a gas analyser
次要结局
- time to obtain an FeO2 at 90%(6 minutes)
- proportion of adequate preoxygenation at 3 min(6 minutes)
- tolerance(1 hour)
- tolerance on VAS(1 hour)