Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™ Laryngeal Mask: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Success rate in first attempt
研究概览
简要总结
In a previous study, NCT03147469, the investigators found that the vocal cords were more easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of this finding, the investigators are going to conduct a randomized controlled trial to evaluate the effect of neck extension on the success rate of blind intubation through laryngeal mask.
Participants undergoing general anesthesia will be randomly assigned to group E (with neck extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if blind intubation succeed. Blind intubation will be performed with a maximum of two attempts. If all attempts failed, the laryngeal mask will be removed and the tube will be intubated using a direct laryngoscopy.
The primary outcome of this study is the success rate of blind intubation within a first attempt. Secondary outcomes included overall success rate of blind intubation within a maximum of two attempts, time for blind intubation, the incidence of postoperative hoarseness, cough, and sore throat, and any obvious complications related to airway management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing general anesthesia with endotracheal intubation
排除标准
- •Emergency operation
- •History of esophageal, oropharyngeal, or laryngeal disease
- •History of cervical spine surgery
- •Insufficient NPO time
- •Loosening teeth
- •Mouth opening less than 2cm
研究组 & 干预措施
Group E
After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning.
干预措施: Ambu® AuraGain™ (Device)
Group E
After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning.
干预措施: neck extension (Procedure)
Group C
After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neutral head and neck position.
干预措施: Ambu® AuraGain™ (Device)
结局指标
主要结局
Success rate in first attempt
时间窗: In a first attempt for blind intubation, an average of 30 seconds
Successful blind intubation in a first attempt
次要结局
- Overall success rate(In a maximum of two attempts for blind intubation, an average of 60 seconds)
- Postoperative cough(24 hours after extubation)
- Postoperative hoarseness(24 hours after extubation)
- Time for blind intubation(In a maximum of two attempts for blind intubation, an average of 60 seconds)
- Postoperative sore throat(24 hours after extubation)
研究者
Jin-Tae Kim
Associate Professor
Seoul National University Hospital
