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临床试验/CTRI/2025/10/096612
CTRI/2025/10/096612尚未招募2/3 期

Tongue width versus weight based method for size determination of laryngeal mask airway in children Randomised Controlled Trial

Dr Sidharth D Nair1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
1 To determine the size of LMA supreme by using tongue width vs weight based method in children

研究概览

简要总结

The study aims to assess the difference in the size determined of a LMA and its ease of insertion by the weight based technique and tongue width based technique and see if the latter can be used as a tool of assessment of the same. Children within the age group of 3 to 12 years are included undergoing surgery under general anaesthesia lasting less than 2 hours and in whom there are no contraindications of LMA insertion or receiving GA

Patients will be evaluated prior to the procedure and the LMA provided is based depending on which group the patient is in. Children in group A shall receive LMA based on tongue width and those in group B on weight based. Once inside the operating room the patient is induced and LMA is inserted

We assess the time taken insert, number of attempts taken, change in size of LMA or ETT, adequacy of ventilation, adequacy of oxygenation and in the peri operative period look for hypoxemia, laryngospasm, bronchospasm, displacement of LMA and blood on cuff on removal. After extubation the child will be monitored for 30 minutes for any new complication. The above mentioned parameters will be noted all while maintaining safety of the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children between the ages 3 to 12 years of either gender for surgery under general anaesthesia with LMA ASA category 1 and 2 Duration of surgery less than 2 hours Adequate nil per oral duration.

排除标准

  • High risk of regurgitation Anticipated difficult airway Weight more than 50 kilograms Contraindication to insertion of LMA Known allergies to drugs used in study.

结局指标

主要结局

1 To determine the size of LMA supreme by using tongue width vs weight based method in children

时间窗: Pre operatively and after induction till 15 minutes | After extubation till 30 minutes

2 To determine the ease of insertion of LMA chosen by using tongue width vs weight based method in children

时间窗: Pre operatively and after induction till 15 minutes | After extubation till 30 minutes

次要结局

  • 1 To assess the hemodynamic response to insertion of LMA supreme(2 To assess post operative complication of insertion of LMA supreme)

研究者

发起方
Dr Sidharth D Nair
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sidharth D Nair

MOSC medical College

研究点 (1)

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