A Randomized Non Crossover Study of the GuardianTM Versus SupremeTM Laryngeal Mask Airway
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- efficacy of oropharyngeal seal pressure
研究概览
简要总结
The investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.
详细描述
The GuardianTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, non-crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the GuardianTM and the LMA SupremeTM in paralyzed, anesthetized patients.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA 1 or 2
- •Age 18-75 yr
- •Written informed consent
排除标准
- •Difficult airway
- •Non fasted
- •BMI > 35
结局指标
主要结局
efficacy of oropharyngeal seal pressure
时间窗: 5 min
this will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O
次要结局
- anatomic position(5 min)
研究者
ChristianKeller
MD, M.Sc.
Schulthess Klinik