The comparison of standard weight based and thenar eminence dimension based selection of I-gel in paediatric patients- A randomized controlled study.

KIMS1 个研究点分布在 1 个国家目标入组 78 人开始时间: 2021年1月3日最近更新: 2021年2月13日

试验速览

阶段: 2 期
状态: 尚未招募
发起方: KIMS
入组人数: 78
试验地点: 1
主要终点: Alternate method of selection of i-gel, which can be applied in cases where the weight of the patient is not known and where the weight is not a reliable factor and can be applied in emergency cases.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Supraglottic airway devices are integral part of general anaesthesia and various anatomical landmarks are being studied as a tool for selection of appropriate size of I-gel. Weight based selection of i-gel may not be suitable for underweight or overweight children and in immobilized or unconscious patients. Hence, first attempt success rate of insertion of igel will be compared among two groups - thenar eminence based and standard weight based among paediatric patients.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Investigator Blinded

入排标准

年龄范围: 6.00 Month(s) 至 15.00 Year(s)（—）
性别: All

入选标准

•ASA grade 1 and grade
•Patients belonging to either sex.
•Scheduled to undergo various short surgical procedures under General anaesthesia using I-gel.
•Patients giving informed written consent .

排除标准

•Patients with suspected airway difficulty( mallampati grade 3 and grade 4) Significant cardiovascular pulmonary and liver diseases.

结局指标

主要结局

Alternate method of selection of i-gel, which can be applied in cases where the weight of the patient is not known and where the weight is not a reliable factor and can be applied in emergency cases.

时间窗: The percentage of successful insertion of i-gel .

次要结局

To compare the ease of insertion and adverse events in thenar eminence size based selection of i-gel in terms of time taken for insertion of i-gel or adverse events associated with insertion of i-gel like coughing, gagging, etc.(2 years)

研究者

发起方

KIMS

申办方类型

Government medical college

研究点 (1)

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