Ambu® Aura-iTM Laryngeal Mask Versus Air-QTM Intubating Laryngeal Airway as Conduits for Tracheal Intubation in Adults. A Randomized Comparative Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- duration of fiberoptic guided insertion of the ETT through the device
研究概览
简要总结
Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice. they can be used as primary airway devices or as conduits for endoracheal intubation and they become an integral part in the recent guidelines for managing difficult airway.
Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal intubation.
The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage over the competitors but not will studied as a conduit for endoracheal intubation.
This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from 18-60 years old, ASA I and II and scheduled for elective surgery under general anesthesia
排除标准
- •history of cardiopulmonary disease, gastro-esophageal reflux disease, abnormal airway anatomy, body mass index > 30 kg.m-2, surgical procedures including head and neck or performed in position other than supine or lithotomy
结局指标
主要结局
duration of fiberoptic guided insertion of the ETT through the device
时间窗: duration of induction of general anesthesia, an expected average of 20 minutes. and it is the time span between disconnection of the breathing circuit from the device till reconnection to the ETT and appearance of 1st capnogram wave.
次要结局
- duration of device insertion(duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span between removal of the face mask till device insertion and the chest rise seen after two consecutive positive pressure manual breaths.)
- Time of device removal(duration of induction of general anesthesia, an expected average of 20 minutes, and it is the time span between disconnection of the breathing circuit from ETT and reconnection to ETT after device removal with appearance of the 1st capnogram wave.)
- complication during the procedure(average of 20 minutes after induction of general anesthesia, it is the time from removal of face mask, till removal of the device and appearance of the first wave on the capnogram)
- number of insertion attempts(duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span from removal of face mask till complete insertion or failed third insertion trial of the device)
- vital sign in form of mean arterial blood pressure, heart rate and oxygen saturation(average of 20 minutes, and it is the time from time of induction of general anesthesia til completion of endotracheal intubation)