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临床试验/CTRI/2025/02/081026
CTRI/2025/02/081026尚未招募1 期

Device Profile Of i-gel: Comparison of two insertion techniques

K S Hegde Medical Academy1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
96
试验地点
1
主要终点
Comparison of device profile of i-gel with 2 techniques of insertion in terms of

研究概览

简要总结

Two insertion techniques for I-gel in paediatric patients undergoing general anesthesia aims to evaluate two methods standard insertion or reverse insertion with jaw thrust provides better placement success, shorter insertion time, and improved airway seal pressure.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients undergoing elective surgeries under general anaesthesia 1.Age of 6 Months-18 Years 2.ASA 1 and 2.

排除标准

  • 1.Refusal to enrol in the study by Parent/Guardian and patient(ASSENT WHERE INDICATED) 2.Patients with Upper Respiratory tract infections 3.Children risk of regurgitation 4.Patients with obvious Airway Pathology.

结局指标

主要结局

Comparison of device profile of i-gel with 2 techniques of insertion in terms of

时间窗: After induction of general anaesthesia | 1.Attempts and ease of insertion of i-gel | 2.After insertion of i-gel for proper placement and oropharyngeal air leak pressure

1.Proper placement of i-gel using Fiberoptic view

时间窗: After induction of general anaesthesia | 1.Attempts and ease of insertion of i-gel | 2.After insertion of i-gel for proper placement and oropharyngeal air leak pressure

2.First attempt success rate

时间窗: After induction of general anaesthesia | 1.Attempts and ease of insertion of i-gel | 2.After insertion of i-gel for proper placement and oropharyngeal air leak pressure

3.Time for insertion

时间窗: After induction of general anaesthesia | 1.Attempts and ease of insertion of i-gel | 2.After insertion of i-gel for proper placement and oropharyngeal air leak pressure

4.Airway seal pressure measured using the peak airway pressure at minimal leak

时间窗: After induction of general anaesthesia | 1.Attempts and ease of insertion of i-gel | 2.After insertion of i-gel for proper placement and oropharyngeal air leak pressure

次要结局

  • Comparison of complication in terms of(1.Additional maneuvers required)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

SHIVANI RATHOD

K S HEGDE MEDICAL ACADEMY

研究点 (1)

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