A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.
详细描述
Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Ⅰ-Ⅲ classification
- •Patients evaluated as eligible for a LMA
- •Body Mass Index ≤35kg/m2
排除标准
- •Patients with known or predicted difficult airway
- •Active respiratory infection
- •Risk of aspiration
- •Head and neck surgery
- •Emergent surgery
研究组 & 干预措施
Ambu AuraGain
Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines
干预措施: Ambu AuraGain (Device)
LMA Supreme
Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines
干预措施: LMA Supreme (Device)
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: Up to 1 minute after the time of confirmed device placement
The airway pressure at which an airway leak is observed after successful placement of the device
次要结局
- Insertion time(Up to 1 minute on each insertion attempt)
- Ease of insertion(Up to 1 minute on each insertion attempt)
- Fiberoptic Grade of Laryngeal View(Up to 1 minute after placement of device)
- Postoperative Complications(2 hours after removal of the device)
研究者
Juhui Liu
Plastic Surgery Hospital
Chinese Academy of Medical Sciences