CTRI/2025/08/092835尚未招募不适用
Comparison of i gel with i gel plus in patients undergoing elective surgeries under general anaesthesia.A prospective randomized double blinded study
SDM COLLEGE OF MEDICAL SCIENCE1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the 1st attempt insertion success rate
研究概览
简要总结
- Study procedure - Ethical committee approval will be taken
- Informed consent will be obtained
- Preoperative evaluation will be done
- Randomly allocated on two groups which will be computer generated
- Standard general anaesthesia steps followed and intubated supine
- Appropriate size of i gel or i gel plus will be choosen
- randomly of size 3,4,5 depending on patient weight (30- 50kg,51-70kg,71-100kg) respectively.
- Successful placement of the i-gel Plus will be confirmed by
- adequate chest rise, presence of bilateral breath sounds on auscultation, and a capnographic waveform consistent with effective ventilation.
- PARAMETERS OBSERVED:
-
- 1 st attempt insertion
-
- Ease of insertion
-
- Time taken for insertion
-
- Any complications
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 2 3 In elective surgery under general anaesthesia expecting to last less than 60min.
排除标准
- •1 Patient refusal 2 Anticipated difficult Airway 3 Risk of aspiration 4 BMI more than 35.
结局指标
主要结局
To compare the 1st attempt insertion success rate
时间窗: 1min,2min,3min,4min,5min,15min,30min,60min
of i-gel and i-gel Plus, defined as the provision of
时间窗: 1min,2min,3min,4min,5min,15min,30min,60min
effective management through the device from
时间窗: 1min,2min,3min,4min,5min,15min,30min,60min
insertion until the end of procedure.
时间窗: 1min,2min,3min,4min,5min,15min,30min,60min
次要结局
- 1.To assess ease and time of insertion. 2.To compare oropharyngeal leak pressure. 3.To evaluate incidence of complications(Intraoperative complications -)
研究者
Dr PREETHI R
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL
研究点 (1)
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