跳至主要内容
临床试验/CTRI/2017/04/008357
CTRI/2017/04/008357已完成不适用

Comparison of clinical performance of Laryngeal Mask Airway Supreme and I-Gel in patients undergoing elective non-laparoscopic surgeries

Jaipur Golden Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年11月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
1.Ease of insertion and time taken for insertion of both the devices

研究概览

简要总结

The latest supraglottic devices like LMA Supreme and I-Gel have been developed to overcome the limitations of currently available supraglottic devices like high cost, demand for careful handling to prevent cuff damage, relative difficulty of insertion and growing concern over the ability to use clean reusable devices.

In this randomized parallel group study we attempt to compare LMA Supreme and I-Gel in anesthetized patients undergoing non laparoscopic surgeries , in terms of ease of insertion, airway sealing pressure, insertion attempts, ease of gastric tube placement, oral or dental trauma, post operative sore throat or hoarseness. Eighty patients aged 18 to 60 years of either sex of ASA physical status 1 and 2 undergoing elective non laparoscopic surgeries will be studied.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of either sex aged between 18 & 60 years 2.Patients with ASA physical status 1 and 2 3.Patients scheduled for elective non laparoscopic surgeries under general anaesthesia.

排除标准

  • 1.Patients with high risk of aspiration 2.Morbid obesity 3.Cervical spine disease 4.Anticipated difficult airway.

结局指标

主要结局

1.Ease of insertion and time taken for insertion of both the devices

时间窗: At the time of intervention

2.Airway sealing pressure with both the devices

时间窗: At the time of intervention

次要结局

  • 1.Ease of gastric tube insertion(2.Oral or Dental trauma)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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