CTRI/2025/11/097055尚未招募不适用
A Randomised comparative Study to evaluate oropharyngeal leak pressure of Self – pressurized Air-Q versus I-Gel Laryngeal Airway in pediatrict patients under general anaesthesia at SMS Medical College Jaipur
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL, JAIPUR1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月15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
- 70
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure of Self -pressurised Air-Q and I-Gel laryngeal airway measured in paediatric patients under general anaesthesia
研究概览
简要总结
A Randomised Study to compare oropharyngeal leak pressure of I-Gel v/s Self – pressurized Air-Q Laryngeal Airway in pediatric patients under general anaesthesia,To find out the effectiveness of supraglottic Airway device Air-Q SP and I-Gel in terms of oropharyngeal leak pressure in pediatric surgical patients under general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Parent/guardian willing to provide consent for participation.
- •Patients of either sex.
- •age 0-5 years weight -0-25 kg ASA GRADE I and II Undergoing elective surgery in supine position requiring general anaesthesia.
排除标准
- •Abnormal airway anatomy assessed by – inadequate mouth opening, micrognathia, thyromental distance, and submental compliance, intra oral growth.
- •Patient with cardiopulmonary disease Severe gastrointestinal reflux History of upper respiratory tract infection in previous 14 days.
- •Syndromic children with difficult airway, intraoral pathology.
结局指标
主要结局
Oropharyngeal leak pressure of Self -pressurised Air-Q and I-Gel laryngeal airway measured in paediatric patients under general anaesthesia
时间窗: 1.Immediately after insertion of the device | 2.After 5 minutes post insertion | 3.At the end of surgery befor device removal
次要结局
- To evaluate and compare fiber optic view of larynx between two study groups.(To evaluate and compare post-operative complications (laryngospasm, sore throat, dysphagia, blood staining of device) between two study groups.)
研究者
Dr Neelam Dogra
SMS MEDICAL COLLEGE, JAIPUR
研究点 (1)
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