Comparison of Baska Mask with I-gel in patients undergoing elective surgery under general anaesthesia : A randomized controlled trial

Director Principal1 个研究点分布在 1 个国家目标入组 68 人开始时间: 2018年2月19日最近更新: 2018年4月7日

试验速览

阶段: 不适用
状态: 招募中
发起方: Director Principal
入组人数: 68
试验地点: 1
主要终点: Oropharyngeal Leak Pressure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomised, single blinded, active controlled trial, comparing Baska Mask and I-gel supraglottic airway devices in patients undergoing elective surgery under general anaesthesia in Government Medical College Hospital, Chandigarh, India. The primary outcome is Oropharyngeal Leak Pressure. The secondary outcomes are ease of insertion, fibreoptic visualisation of glottis, hemodynamic and ventilation parameters and postoperative complications.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•American Society of Anaesthesiologist (ASA) physical status I and II Patients scheduled for elective surgery under general anaesthesia ( duration of surgery 2+/-0.5hrs).

排除标准

•Patients with : 1)anticipated difficult airway (ADS>8) 2)upper respiratory tract infection 3)increased risk of regurgitation and aspiration of gastric content 4)BMI >35kg/m2 5)history of radiotherapy to neck involving the hypopharynx 6)undergoing surgeries involving neck and oral cavity 7)pregnancy.

结局指标

主要结局

Oropharyngeal Leak Pressure

时间窗: 0-5 minutes after device insertion

次要结局

Ease of insertion,fibre optic visualisation of glottis, hemodynamic and ventilation parameters,postoperative complications(At 0,5,10,15 minutes of device insertion)

研究者

发起方

Director Principal

申办方类型

Research institution and hospital

研究点 (1)

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