A Comparative evaluation of performance of newer cuffless supraglottic devices: GMA Tulip versus SLIPA3G:A prospective randomised study in adults patients undergoing surgery under general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate and compare oropharyngeal leak pressure between GMA-Tulip and SLIPA3G
研究概览
简要总结
This study is to compare the oropharyngeal leak pressure between two supraglottic devices SLIPA3G and GMA-Tulip in 18-60year ASA I and II patients undergoing surgery under general anaesthesia. Time taken for device placement, first attempt success rate of two devices, ease of device placement, fibreoptic grade of device placement and hemodynamic variations will be studied. Data will be compiled and appropriate stastical test will be used to analyse the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patient aged between 18 to 60 years, having ASA status I or II and patients undergoing surgery under general anaesthesia where placement of supraglottic device is indicated.
排除标准
- •Respiratory or Pharyngeal pathology Mouth opening less than 2 cm BMI more than 30kg/m2 Pregnancy Full stomach.
结局指标
主要结局
To evaluate and compare oropharyngeal leak pressure between GMA-Tulip and SLIPA3G
时间窗: The performace of Two gadgets will be compared after insertion, throughout the operative procedure and removal of device. surgical period may last from one hour to 2 hours. Mean arterial pressure, Heart rate, Sp02 will be evaluated at baseline, after induction, after device placement and 5 minutes after device placement
次要结局
- Time taken for device placement(First attempt success rate of two devices)
研究者
Dr Kiranpreet Kaur
Pt.B.D. Sharma PGIMS Rohtak