NCT01425151已完成不适用
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients
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
- 60
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I and II
- •Age 1.5-6 years
排除标准
- •known or predicted difficult airway
- •body mass index > 35 kg m-2
- •risk of aspiration
研究组 & 干预措施
i-Gel
Active Comparator
干预措施: i-Gel (Device)
ProSeal
Experimental
干预措施: ProSeal (Device)
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 10 Minutes
次要结局
- Insertion success rate(1 Minute)
研究者
ChristianKeller
MD, M.Sc.
Schulthess Klinik
研究点 (2)
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