Blind Tracheal Intubation Through the Air-Q Intubating Laryngeal Airway in Pediatric Patients. Re-evaluation. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- The first trial success rate
研究概览
简要总结
To compare the success rate of blind technique with correction manoeuvres versus fiber optic- guided Intubation through the air Q laryngeal airway in pediatric patients
详细描述
A prior G-power analysis was done to estimate the sample size. The primary outcome of this study was the first trial success rate. Using fibre exact test and assuming alpha (type I error) = 0.05 and beta (type II error) = 0.2 (power =80%), 58 patients per group would be sufficient to detect a difference 10 % in success rate among the groups. A drop out 10% of cases was expected; therefore 63 patients were required in each group to detect the difference.
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
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I-II
- •Body weight from 4 to 30 kg
排除标准
- •History of gastroesophageal reflux
- •History of hyperactive airway
- •Patients with congenital disorders associated with difficult airway
研究组 & 干预措施
Blind tracheal intubation through AirQ
Patients were intubated through the air-Q blindly
干预措施: Blind tracheal intubation through AirQ (Procedure)
Fiberscopic tracheal intubation through AirQ
Patients were intubated through the air-Q using fibreoptic bronchoscope
干预措施: Fiberscopic tracheal intubation through AirQ (Procedure)
结局指标
主要结局
The first trial success rate
时间窗: during first trial of intubation procedure
percentage of cases of successful tracheal intubation during the first trial
次要结局
- Time to ventilation(procedure (Time from beginning of air-Q insertion till full capno-graphic wave))
- Time to intubation(procedure (Time from beginning of manipulation of the ETT till full capno-graphic wave))
- Heart rate(After induction of anesthesia till 10 minutes after intubation)
- blood staining of the device(from extubation till 24 hours after extubation)
- The total success rate(from beginning of manipulation of the endotracheal tube till end of second trial either by successful intubation or failed intubation procedure)
- Mean arterial blood pressure(After induction of anesthesia till 10 minutes after intubation)
- post-intubation croup(from extubation till 24 hours after extubation)
- hoarsenes(from extubation till 24 hours after extubation)