NCT03411655Unknown不适用
A Randomised Non Crossover Study Comparing Ambu® Aura-ITM and Ambu® Aura GainTM for Fiberoptic Intubation in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Fiberoptic intubation
研究概览
简要总结
The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients
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
- Single (Investigator)
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
- •age 1.5 - 6 years
- •minor surgery
- •extraglottic airway device
排除标准
- •age (<18 months, >6 years)
- •weight (<10 kg, >20 kg)
- •a known difficult airway
- •risk of aspiration
研究组 & 干预措施
Ambu® Aura-ITM
Active Comparator
干预措施: Ambu® Aura-ITM (Device)
Ambu Aura GainTM
Active Comparator
干预措施: Ambu Aura GainTM (Device)
结局指标
主要结局
Fiberoptic intubation
时间窗: 5 minutes
The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)
次要结局
未报告次要终点
研究者
Christian Keller
MD M.Sc.
Schulthess Klinik
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