Directly Measured Mucosal Pressure for Two Different Extraglottic Airway Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- pharyngeal mucosal pressure
研究概览
简要总结
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized females.
Thirty females aged 19-65 years were randomly allocated to receive either the size 4 LMA Supreme or i-Gel for airway management. Microchip sensors were attached to the LMA Supreme/i-Gel at four locations corresponding to the A, base of tongue; B, distal oropharynx; C, hypopharynx; and D, pyriform fossa.
Insertion success rate and oropharyngeal leak pressure were also measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 19-65 years
排除标准
- •< 19 years
- •had a known or predicted difficult airway
- •a body mass index > 35 kg m-2, or
- •were at risk of aspiration
研究组 & 干预措施
Laryngeal Mask Airway Supreme
Directly measured mucosal pressures
干预措施: Laryngeal Mask Airway Supreme (Device)
i-Gel
Directly measured mucosal pressures
干预措施: i-Gel extraglottic airway device (Device)
结局指标
主要结局
pharyngeal mucosal pressure
时间窗: every 5 minutes during steady state anesthesia
次要结局
未报告次要终点
研究者
ChristianKeller
MD, M.Sc.
Schulthess Klinik