A prospective randomized comparison of GMA-Tulip versus i-gel in adult patients undergoing general anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the oropharyngeal leak
研究概览
简要总结
This study is to compare the clinical performance of two supraglottic devices i.e. GMA-Tulip and i-gel. Adult patients aged between 18-60 years of either sex of ASA grade 1 and 2 scheduled for elective surgery requiring general anaesthesia and endotracheal intubation will be included. Oropharyngeal Leak Pressure, Number of attempts, time taken for intubation, first pass, success rate of intubation, ease of intubation, optimisation manoeuvres required for intubation and haemodynamic variations after induction, after insertion and five minutes after the device placement will be noted. Data will be compiled and appropriate statistical test will be used to analyze 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
- •One hundred patients of either sex aged 18-60 years belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled for elective surgery under general anaesthesia where placement of supraglottic device is indicated will be included in the study.
排除标准
- •Patients having respiratory or pharyngeal pathology, mouth opening less 2.0cms, Body mass index more 30kgm-2, pregnancy, full stomach, will be excluded from the study.
结局指标
主要结局
To compare the oropharyngeal leak
时间窗: 1. 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. | MAP, HR, Sp02 will be evaluated at baseline, after induction, after device placement and 5 minutes after device placement
pressure as a measure of placement and airway seal
时间窗: 1. 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. | MAP, HR, Sp02 will be evaluated at baseline, after induction, after device placement and 5 minutes after device placement
次要结局
- Assess the time taken for device placement, the ease of insertion & first-attempt(success rate)
研究者
Dr Prashant Kumar
Pt. B.D. Sharma PGIMS, Rohtak