Comparison of Comparison of McGrath Videolaryngoscopy and Direct Laryngoscopy for Rapid Sequence Intubation: an International, Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Visualization of the Vocal Cords
研究概览
简要总结
The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
详细描述
The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery requiring oral endotracheal intubation for general anesthesia;
- •Anticipated extubation in the operating room;
- •American Society of Anesthesiologists (ASA) physical status 2-3;
- •Age between 18 and 99 years;
- •Body Mass index ≥ 40 kg/m2.
排除标准
- •Refusal of participation by attending anesthesiologist;
- •Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
- •Indicated fiberoptic awake intubation.
结局指标
主要结局
Visualization of the Vocal Cords
时间窗: From the start time of intubation to time of the end of surgery, up to 12 hours.
The visualization of the vocal cords, defined using the modified Cormack and Lehane classification: Grade I: Full view of the glottis (vocal cords are completely visible). Grade IIa: Partial view of the glottis (only the posterior portion of the glottis is visible). Grade IIb: Only the arytenoids or the posterior extremity of the vocal cords are visible (the anterior commissure is not seen). Grade III: Only the epiglottis is visible (the glottis is not visible). Grade IV: Neither the epiglottis nor the glottis is visible (only the soft palate is seen).
次要结局
- Number of Participants With 1, 2, 3, and 4 Intubation Attempts(From the start time of intubation to time of the end of surgery, up to 12 hours.)
- Intubation Failure.(From the start time of intubation to time of the end of surgery, up to 12 hours.)