Comparison of Oropharyngeal Leak Pressure Between the Ambu AuraGain and the LMA Supreme - a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Oropharyngeal leak pressure (OLP) for each airway device after insertion
研究概览
简要总结
The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Oropharyngeal leak pressure (OLP) for each airway device after insertion
时间窗: Within 2-3 minutes after laryngeal mask insertion before start of surgery.
OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'.
次要结局
- Satisfaction of patient and the anesthesiologist with the device(After 1hr in the post anesthesia care unit (PACU))
- Postoperative nausea and vomiting (PONV)(at 1 hr, 2hr and 24 hrs after the surgery)
- Phrayngolaryngeal complications(at 1 hr, 2hr and 24 hrs after the surgery)
研究者
David Wong
Professor
University Health Network, Toronto