A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- requirement of additional airway maneuver
研究概览
简要总结
Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.
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
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status: 1-3
- •age: from 6 months to 6 year
- •body weight: 5-20kg
- •patients undergoing upper/lower extremity surgery at supine position
排除标准
- •patients who do not want to participate in this study
- •patients with known difficult airway including congenital facial anomaly or history of difficult airway management
- •patients with aspiration risk (gastrointestinal stenosis or stricture)
- •patients with symptom of upper respiratory infection on the day of surgery
- •patients scheduled for day surgery
- •patients judged as not eligible by researchers for other reasons
研究组 & 干预措施
AuraGain
After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg.
干预措施: AuraGain (Device)
I-gel
After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg.
干预措施: I-gel (Device)
结局指标
主要结局
requirement of additional airway maneuver
时间窗: during placement/maintenance of the device
including adjustment of head/neck position or insertion depth and taping of the device
次要结局
- insertion time(during placement of the device)
- ease of gastric tube insertion(within 10 minutes after device insertion)
- adverse effect at operating room(during anesthesia)
- postoperative adverse effect(within postoperative 24 hours)
- oropharyngeal leak pressure(at 1 minute after device insertion, at 10 minutes after device insertion)
- fiberoptic view of glottis(within 10 minutes after device insertion)
- success rate(during placement of the device)
研究者
Hajung Kim
Clinical Instructor
Asan Medical Center