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临床试验/NCT03408431
NCT03408431已完成不适用

Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™ Laryngeal Mask: a Randomized Controlled Trial

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2018年1月25日最近更新:
适应症
干预措施

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

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

Experimental

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

Associate Professor

Seoul National University Hospital

研究点 (2)

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