Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Success of orotracheal or nasotracheal intubation.
研究概览
简要总结
The airway management is a vital act in anesthesia. The gold standard technique for planned very difficult intubation is nasotracheal fiberoptic intubation. The success rate with this procedure is 98.8%. However, learning this technique is difficult and it's considered uncomfortable by patients and practitioners.
The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases of awake intubation by Airtraq® have been described.
Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert recommendations (2017) on difficult intubation, proposes the use of video laryngoscopes as an alternative to the fiberoptic bronchoscope.
We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a awake intubation compared to the gold standard (fiberoptic bronchoscope). This prospective randomized study should include 78 patients in two groups. The purpose of this study is to improve the comfort of patient and practitioner during an awake tracheal intubation, to facilitate the learning of the technique.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Formal indication of awake intubation or patient with two criteria of difficult intubation and ventilation
- •Major patient
- •Patient able to understand oral and written information
排除标准
- •Mouth opening (inter-incisor distance) <16 mm does not allow insertion of the Airtraq® videolaryngoscope
- •Surgery requires nasotracheal intubation
- •Loco-regional anesthesia of larynx impossible
结局指标
主要结局
Success of orotracheal or nasotracheal intubation.
时间窗: 1 day
Defined by the visualization of the tube into the trachea through vocal cords and by the appearance of the capnogram
次要结局
- Rate of occurrence of adverse events(1 day)
- Patient satisfaction score(1 day)
- Length of the proceedings(1 day)
- Operator satisfaction score(1 day)
- Number of intubation attempts(1 day)