An Investigation of a New Laryngeal Mask Airway LMA Protector
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of insertion attempts
研究概览
简要总结
Evaluation of LMA Protector
详细描述
This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •planned elective surgery with indication for LMA use
排除标准
- •body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm
研究组 & 干预措施
LMA Protector
Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)
干预措施: LMA Protector (Device)
结局指标
主要结局
Number of insertion attempts
时间窗: 5 minutes
Time of pickup of device to the presence of carbon dioxide trace on
次要结局
- Oropharyngeal Leak Pressure(5 minutes)
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital