A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.
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
- None
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children < 7 years old who scheduled for general anesthesia using supraglottic airway
排除标准
- •Children who require tracheal intubation
- •Emergency operation without nil per os
- •History of C-spine surgery or disease
- •History of Esophageal disease or surgery
研究组 & 干预措施
AuraGain group
AuraGain is inserted for maintenance of general anesthesia. The size 1 is for children <5kg, size 2 for 5-10kg, size 2 for 10-20kg, and size 2.5 for 20-30kg.
干预措施: AuraGain (Device)
I-gel group
I-gel is s inserted for maintenance of general anesthesia. The size 1 is for children weighted 2-5kg, size 2 for 5-12kg, size 2 for 10-25kg, and size 2.5 for 25-35kg.
干预措施: I-gel (Device)
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 30 seconds after AuraGain or I-gel insertion
The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate is fixed at 3 liter/min
次要结局
- Peak inspiratory pressure(through study completion, an average of 1 hour)
- Ease of gastric tube insertion(Within 5 minutes after anesthetic induction)
- Success rate(Within 5 minutes after anesthetic induction)
- Ease of AuraGain or I-gel insertion(Within 5 minutes after anesthetic induction)
- fiberoptic bronchoscopic veiw(Within 10 minutes after anesthetic induction)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital