跳至主要内容
临床试验/CTRI/2020/01/022633
CTRI/2020/01/022633已完成不适用

COMPARISON OF CLINICAL PERFORMANCE OF I-GEL, LMA SUPREME AND AMBU AURA GAIN IN ADULT PATIENTS DURING GENERAL ANAESTHESIA.

LAKSHMI TEJASHRI C1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年10月1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
clinical performance for successful insertion of the supraglottic airway device.

研究概览

简要总结

As there are many supraglottic airways used widely for airway management during general anaesthesia, the aim of this study is to prove the clinical performance of three supraglottic airway devices i.e. the LMA Supreme, Ambu Aura gain and i-gel in adult patients in general anaesthesia.

Subjects will be ASA I patients for elective surgery who will be randomly allocated into the i-gel group, LMA Supreme group and the Ambu Aura Gain group.  We will compare the time for successful insertion in the first attempt as the primary outcome, and the secondary outcomes will be ease of insertion, oropharyngeal leak pressures, required attempts for SAD insertion, requires attempts for gastric tube placement, quality of airway with controlled ventilation during maintenance of anaesthesia and any associated complications.

Our results will suggest the better alternative of the supraglottic airway device in comparison with the others which will be based on the clinical performance of the supraglottic airway devices.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patient posted for laparoscopic cholecystectomy and other laparoscopic procedures.

排除标准

  • Patients negative consent to be part of study.

结局指标

主要结局

clinical performance for successful insertion of the supraglottic airway device.

时间窗: at the basline

次要结局

  • OROPHARYNGEAL LEAK PRESSURE(1 HOUR)
  • EASE OF INSERTION(5 MINUTES)
  • REQUIRED ATTEMPTS OF INSERTION(1 HOUR)
  • REQUIRED ATTEMPTS OF GASTRIC TUBE PLACEMENT.(1 HOUR)
  • QUALITY OF AIRWAY WITH CONTROLLED VENTILATION DURING THE MAINTENANCE OF ANAESTHESIA.(1 HOUR.)
  • COMPLICATIONS.(5 HOURS)

研究者

发起方
LAKSHMI TEJASHRI C
申办方类型
Other [self]

研究点 (1)

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