Facial Mask Tightness: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask
研究概览
简要总结
A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •edentulous patients
- •age > 55 years
排除标准
- •pregnancy or breast-feeding, patients on tutelage or guardianship
- •patient unable to understand the protocol
- •anesthesia in emergency or with full stomach
研究组 & 干预措施
standard face masks
The standard mask is used in usual care
干预措施: standard mask (Other)
QuadraLite face masks
This study will compare tightness of 2 face masks during preoxygenation and after induction of anesthesia with propofol, sufentanil and rocuronium. During preoxygenation, a 10 l.min-1 fresh gas flow and 8 cm H2O PEEP will be applied. After induction of anesthesia, patients will receive pressure-controlled ventilation (fresh gaz flow 3 L.min-1, pressure set to obtain a 7 ml.kg-1 ideal body weight, 10 cpm, peep 5 cm H2O).
干预措施: QuadraLite masks (Device)
结局指标
主要结局
significant leakage (ie greater than 20% of the current volume) between QuadraLite® mask and facial mask
时间窗: 10 minutes
次要结局
未报告次要终点