NCT03984032已完成不适用
Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Liu Chian Yong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月17日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure (OLP)
研究概览
简要总结
Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.
排除标准
- •BMI > 35
- •Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)
- •Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)
研究组 & 干预措施
LMA Protector Cuff Pilot
Experimental
干预措施: LMA Supreme (Device)
LMA Supreme
Active Comparator
干预措施: LMA Protector Cuff Pilot (Device)
结局指标
主要结局
Oropharyngeal leak pressure (OLP)
时间窗: During induction of anaesthesia
To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme
次要结局
- Mean time to insertion(During induction of anaesthesia)
- Laryngeal view(After induction of anaesthesia)
- Gastric tube insertion(After induction of anaesthesia)
- Complications(24 hours)
研究者
Liu Chian Yong
Consultant Anaesthesiologist
Universiti Kebangsaan Malaysia Medical Centre
研究点 (1)
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