跳至主要内容
临床试验/CTRI/2023/11/060186
CTRI/2023/11/060186已完成不适用

A Randomised controlled trial comparing I-gel, Ambu Auragain and Baska Mask for Fiberoptic view and Oropharyngeal Leak pressure in adult patients undergoing General Anaesthesia

Sardar Patel Medical Collage Bikaner Rajasthan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年2月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
To compare the Fiberoptic view and the Oropharyngeal leak pressure between I-gel, Ambu Auragain and Baska Mask after insertion

研究概览

简要总结

Supraglottic Airway Devices are meant to provide clear airway in a quicker manner and are designed to overcome the disadvantages of endotracheal intubation like soft tissue injury, exaggerated hemodynamic response and barotrauma. The advantages of supraglottic Devices include less invasiveness, avoidance of laryngoscopy, ease of placement, improved hemodynamic stability and less airway related morbidity. The newer second and third generation supraglottic airway devices are provided with safety features of integrated bite block, gastric drainage channel and also has a higher Orpharyngeal leak pressure reducing the risk of aspiration. In this study we are comparing the fiberoptic view and oropharyngeal Leak pressure of I-gel, Ambu Auragain and Baska Mask in adult patients under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA category I and II, undergoing any type of surgery in supine position under general Anesthesia be included in the study after getting informed consent.

排除标准

  • Patient refusal to give consent, Patients with anticipated difficult airway, having upper respiratory tract infection, patients at risk of gastroesophageal regurgitation, history of upper gastrointestinal surgery, adults having limited mouth opening and mass in pharyngeal/laryngeal cavity will be excluded from the study.
  • The patients in whom the insertion was not successful even after three attempts will get excluded from the study.

结局指标

主要结局

To compare the Fiberoptic view and the Oropharyngeal leak pressure between I-gel, Ambu Auragain and Baska Mask after insertion

时间窗: To compare the Fiberoptic view and the Oropharyngeal leak pressure between I-gel, Ambu Auragain and Baska Mask after 5 minutes of insertion

次要结局

  • To compare the number of attempts, Ease of insertion, Complications between I-gel, Ambu Auragain and Baska Mask(Till the point of insertion of second and third generation of supraglottic airway devices)

研究者

发起方
Sardar Patel Medical Collage Bikaner Rajasthan
申办方类型
Government medical college

研究点 (1)

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