Comparative evaluation of ambu aura-I and fastrachTM intubating laryngeal mask airway for tracheal intubation: A Randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1) To evaluate the effectiveness of intubation with Fastrach TM LMA and Ambu aura-i in Anticipated Difficult Airway Management
研究概览
简要总结
Supraglottic airway devices (SADs) play a criticalrole in the airway management.
In any situation where intubation cant be done, theAmerican Society of Anesthesiologists (ASA), Difficult Airway Society (DAS),and Obstetric Anaesthetists’ Association and DAS guidelines recommends the useof SADs as conduit for tracheal intubation.
The FastrachTM-laryngeal mask airway was designed to provide bothventilation and ability to pass a tracheal tube blindly into the trachea.
TheAmbu Auraâ€i is singleâ€use intubating SAD, also designed forboth ventilation and as a conduit for tracheal intubation.
| After extensive research on the literature, it is found that there is not enough data available on the tracheal intubation assessment with Ambu Aura-i. Hence, the present study will be done to compare the tracheal intubation using FTâ€LMA and Auraâ€i in adults. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Â·Age 18 to 60 years ·ASA 1 and 2.
排除标准
- •Â·Younger than 18 years old ·American Society of Anaesthesiologists physical status IV or V · Diagnosed with respiratory tract pathology or coagulation disorders requiring a nasal route for tracheal intubation ·Those at risk of regurgitation–aspiration (previous upper gastrointestinal tract surgery, known hiatus hernia, esophageal reflux, peptic ulceration, or not fasted).
结局指标
主要结局
1) To evaluate the effectiveness of intubation with Fastrach TM LMA and Ambu aura-i in Anticipated Difficult Airway Management
时间窗: 18 months
2) To evaluate the time taken and number of attempts for intubation with FastrachTM and Ambu Aura-i in Anticipated Difficult Airway Management.
时间窗: 18 months
次要结局
- FastrachTM intubating LMA is better than Ambu aura-i LMA(18 months)