A Comparison of the C-mac and Bonfils Intubation Fibrescope for Tracheal Intubation in Patients With a Simulated Difficult Airway
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Success of intubation on first attempt
研究概览
简要总结
The study aims to determine the better device to facilitate intubation in patients with a limited neck movement and small mouth opening. This may help anesthesiology as well as emergency medicine practitioners and departments to decide when choosing between these two conceptually similar device. The hypothesis to be tested is that the C-MAC® is more superior when compared to the Bonfils Intubation Fibrescope in success of intubation, time to intubation and complication rate in patients with a fixed cervical collar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective surgery under general anaesthesia who require endotracheal intubation
排除标准
- •Patients with history of previous difficult endotracheal intubation
- •Patients with two or more predictors of difficult mask ventilation or difficult intubation or the combination of both
- •Patients with ASA (American Society of Anesthesiologists) grading of III and above are excluded from the study, as well as patients with 2 or more predictors for difficult mask ventilation or difficult intubation or the combination of both.
- •Patients needing a rapid sequence induction for rapid securement of the airway
- •Pregnant women
- •Patients below the age of 21 years old
- •Patients unfit to give consent
结局指标
主要结局
Success of intubation on first attempt
时间窗: up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after first attempt at intubation
A rigid cervical collar will to each patient to stimulate a difficult airway and standard induction of general anaesthesia will be carried out. Adequate muscle relaxation will be confirmed by the use of a standard neuromuscular Train-of-Four monitor, showing no twitch. Intubation will then proceed with the assigned airway device. A successful outcome at intubation will involve being able to pass an appropriately sized endotracheal tube pass the vocal cords into the trachea on the first try, as evidenced by the presence of end tidal carbon dioxide on a capnograph.
次要结局
- Time taken to successful intubation(up to 10min - from time of induction to appearance of end tidal carbon dioxide on capnograph after successful intubation)