Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children
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
- time taken to successful intubation
研究概览
简要总结
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
- •Classified by the American Society of Anesthesiology (ASA) as grade 1-
- •Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.
排除标准
- •inability of patient or parents to understand the study or consent process
- •known or suspected difficult airway
- •ASA 4 and above
结局指标
主要结局
time taken to successful intubation
时间窗: 30 mins
The primary outcome measure will be time taken to successful intubation. This will be recorded by a second operator using a handheld stopwatch or wall clock with second hand. Time will commence when the intubation device is handed to the anaesthetist, and stopped after the first successful inflation of the lungs (first upstroke of capnography trace).
次要结局
- Grade of laryngoscopy(30 mins)
- POGO score(30 mins)
- VAS ease of intubation(30 mins)
- evidence of traumatic intubation(24 hours)
研究者
Michelle White
Consultant in Paediatric Anaesthesia and Critical Care
University Hospitals Bristol and Weston NHS Foundation Trust