CTRI/2018/03/012287已完成4 期
Comparison of Proseal LMA with I-gel in children under controlled Ventilation
Tejesh C A1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年1月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- compare the two devices in terms of oropharyngeal sealing pressure under controlled ventilation in children
研究概览
简要总结
This was a randomised study comparing the two supraglottic airway devices Proseal LMA and I-gel in 70 ASA 1 & 2 children aged 1-10years, weighing 10-30kg who are scheduled to undergo elective surgery under general anaesthesia. The primary outcome was to compare the oropharayngeal sealing pressure among the two devices.The oropharyngeal sealing pressure with the two devices was similar between the two devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children weighing between 10-30kgs 2)American Society of Anaesthesiologists (ASA) Grade I and II 3)Duration of surgery <2hrs.
排除标准
- •Anticipated difficult airway.
- •History of obstructive sleep apnoea.
- •Risk of aspiration of gastric contents.
- •Laproscopic surgeries.
- •Prone position.
- •Intraoral surgeries.
结局指标
主要结局
compare the two devices in terms of oropharyngeal sealing pressure under controlled ventilation in children
时间窗: Oropharyngeal sealing pressure will be assessed immediately after insertion of the device
次要结局
- Success rate, insertion time, ease of insertion, fibreoptic-laryngeal view and ability to pass gastric tube of Proseal LMA and i-gel(Immediately after insertion of the device)
研究者
研究点 (1)
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