A Randomized Comparison of Ambu® AuraGain™ Laryngeal Mask Airway and I-gel in Patients With Simulated Cervical Immobilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
The supraglottic airway device(SAD), as an alternative to the endotracheal tube is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. SAD has evolved in recent years to increase efficiency and secure safety. The recently developed Ambu® AuraGain™ is a second-generation SAD with a built-in gastric port and is designed to be fitted well in the larynx and oral cavity after insertion because the shaft is bent at an angle of 90 degrees and has an inflatable cuff.
In a previous study, Ambu® AuraGain™ showed a higher sealing pressure and better fibreoptic finding compared to LMA Supreme in laparoscopic surgery.
On the other hand, I-gel and Ambu® AuraGain™, both of the second-generation SAD, show comparatively excellent performance according to the results of previous studies. However, there are no studies comparing the characteristics of two airway devices in adults.
The purpose of this study is to compare the performance of I-gel and Ambu® AuraGain™ to make a difficult airway-like situation using cervical collar for adult patients receiving mechanical ventilation under general anesthesia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate.
排除标准
- •Body mass index > 35 kg/m2
- •High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
- •Criteria for difficult airway
- •Patients with cervical disease or previous cervical spine surgery
研究组 & 干预措施
Ambu® AuraGain™ group
干预措施: Ambu® AuraGain™ (Device)
I-gel group
干预措施: I-gel (Device)
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: At an average of 30 seconds after insertion of laryngeal mask airway
Oropharyngeal leak pressure is measured by closing the expiratory valve and administering fresh gas flow of 6 L/min, until the equilibrium pressure is reached (to a maximum of 40 cm of H2O).
次要结局
- Oropharyngeal leak pressure(At 5 minute after insertion of laryngeal mask airway)
- The time for successful gastric tube placement(During induction of anesthesia, an average of 5 minutes)
- The number of airway maneuvers required to maintain airway patency(During the surgery, an average of 2 hours after anesthesia induction)
- Overall success rate(During induction of anesthesia, an average of 60 seconds)
- The time for successful insertion of the device(During induction of anesthesia, an average of 60 seconds)
- The grade of fiberoptic bronchoscopic view(During induction of anesthesia, an average of 5 minutes)
- Postoperative complications(An average of 2 hours after extubation)
- The number of attempts at insertion of device(During induction of anesthesia, an average of 60 seconds)
- The ease of gastric tube placement(During induction of anesthesia, an average of 5 minutes)
- Intraoperative complications(During the surgery, an average of 2 hours after anesthesia induction)
- Success rate in first attempt(During induction of anesthesia, an average of 60 seconds)
- The ease of insertion of device(During induction of anesthesia, an average of 60 seconds)
- Peak inspiratory pressure(At 5 minute after insertion of laryngeal mask airway)
- The type of airway maneuvers required to maintain airway patency(During the surgery, an average of 2 hours after anesthesia induction)
研究者
Tae Kyong Kim
Clinical professor
Seoul National University Hospital