Comparison of the New Flexible Tip Bougie Catheter and Standard Bougie Stylet for Tracheal Intubation by Anesthesiologists in Different Difficult Airway Scenarios: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- time to intubation
研究概览
简要总结
We, therefore conducted a randomized cross over study to evaluate the usefulness of this new device use by experienced anesthesiologists in several airway manikin scenarios. We hypothesized that in the hands of experienced anesthesiologists the new Flexible Tip Bougie catheter would perform comparably to the standard bougie catheter) in the normal airway scenario. In the difficult airway (both tongue edema, manual in-line stabilization, or cervical collar stabilization), we hypothesized that the new Flexible Tip Bougie catheter would prove superior to the standard Bougie stylet.
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
- Single (Outcomes Assessor)
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
- •physicians
- •give voluntary consent to participate in the study
- •none experience in videolaryngoscopy
- •less than 1 year experience in medicine
排除标准
- •not meet the above criteria
- •wrist or low back diseases
研究组 & 干预措施
Normal airway
intubation in normal aurway condition
干预措施: the standard Bougie stylet for difficult intubation (Device)
Normal airway
intubation in normal aurway condition
干预措施: The new Flexible Tip Bougie catheter (Device)
Tongue edema
intubation in Tongue edema condition
干预措施: the standard Bougie stylet for difficult intubation (Device)
Tongue edema
intubation in Tongue edema condition
干预措施: The new Flexible Tip Bougie catheter (Device)
Pharyngeal obstruction
intubation in Tongue edema condition
干预措施: the standard Bougie stylet for difficult intubation (Device)
Pharyngeal obstruction
intubation in Tongue edema condition
干预措施: The new Flexible Tip Bougie catheter (Device)
Manual cervical inline stabilization
intubation in Manual cervical inline stabilization condition
干预措施: the standard Bougie stylet for difficult intubation (Device)
Manual cervical inline stabilization
intubation in Manual cervical inline stabilization condition
干预措施: The new Flexible Tip Bougie catheter (Device)
Cervical collar stabilization
intubation in Cervical collar stabilization condition
干预措施: the standard Bougie stylet for difficult intubation (Device)
Cervical collar stabilization
intubation in Cervical collar stabilization condition
干预措施: The new Flexible Tip Bougie catheter (Device)
Cervical collar stabilization and pharyngeal obstruction
intubation in Cervical collar stabilization and pharyngeal obstruction condition
干预措施: the standard Bougie stylet for difficult intubation (Device)
Cervical collar stabilization and pharyngeal obstruction
intubation in Cervical collar stabilization and pharyngeal obstruction condition
干预措施: The new Flexible Tip Bougie catheter (Device)
结局指标
主要结局
time to intubation
时间窗: 1 day
time from pick up device to the final placement tube in trachea
次要结局
- Ease of use(1 day)
- Number of optimalization maneuvers(1 day)
- success of intubation(1 day)
- Dental compression(1 day)