NCT02811042Unknown不适用
Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position
适应症
干预措施
试验速览
- 阶段
- 不适用
- 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
The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized 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
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 1 - 16 years
- •minor surgery
- •extraglottic airway device
排除标准
- •age (<12 months, >16 years)
- •weight (<12 kg, >50 kg)
- •a known difficult airway
- •risk of aspiration
研究组 & 干预措施
Oropharyngeal leak pressure
Active Comparator
Ambu AuraOnce
干预措施: Ambu AuraOnce (Device)
Fiberoptic position
Experimental
Ambu AuraGain
干预措施: Ambu AuraGain (Device)
结局指标
主要结局
oropharyngeal leak pressure
时间窗: 5 min
次要结局
- fiberoptic position(5 min)
研究者
ChristianKeller
PD Dr. med. M.Sc.
Schulthess Klinik
研究点 (2)
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