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临床试验/CTRI/2024/07/069882
CTRI/2024/07/069882已完成4 期

Clinical study comparing ultrasound, age and height based estimation of endotracheal tube size in pediatric patients

Dr Moopens Medical College1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年7月18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
78
试验地点
1
主要终点
To find out the most efficient way to estimate the size of endotracheal tube in pediatric patients by comparing ultrasound scan, age based formula or height based formula

研究概览

简要总结

The primary objective of the study is to find out the accurate method of estimating the size of Endotracheal tube which will be used for intubations for surgeries. In current practice endotracheal tube size is estimated using age based formula and height based formula but, in our study we are doing an ultrasound scan of the front of the neck to estimate the appropriate size of endotracheal tube to be used. Hence, in this study, a total of 78 healthy patients aged 5years to 14years undergoing elective surgeries under general anesthesia will be recruited,

The total sample size will be divided into 3 groups of 26 each.

Group U will undergo an ultrasound scan of the front of the neck to estimate the size of endotracheal tube.

Group A will use age based formula to calculate the appropriate size of the endotracheal tube and

Group H will use patients height to estimate the size of the endotracheal tube.

This study is relevant because choosing the wrong size of endotracheal tube can cause multiple complications related to the larynx and the trachea. Also, the Age and Height based formulas were designed for western children and the same measurements are not accurate for our pediatric population. Hence In this study we are comparing a non invasive, painless, novel modern technique using ultrasound scan to estimate the size of endotracheal tube in pediatric patients undergoing elective surgeries.

The primary Objective of this study is to find out which method is more accurate in estimating endotracheal tube size by performing a ’leak test’ on the ventilator to see if the size is appropriate.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • 78 patients aged 5 years to 14 years who are healthy with no co morbidities undergoing elective surgeries under general anesthesia are included in the study.

排除标准

  • Patients with difficult airway, patients with history of delayed growth milestones, patients with respiratory or cardiac diseases, presence of any neck mass or swelling.

结局指标

主要结局

To find out the most efficient way to estimate the size of endotracheal tube in pediatric patients by comparing ultrasound scan, age based formula or height based formula

时间窗: Leak test will be performed at baseline and every 5 minutes until the end of surgery

次要结局

  • Measure ease of insertion using 3 point scale of easy, difficult & no intubation(at baseline & every 5 minutes until the end of surgery & every hour after that until 24 hours)

研究者

发起方
Dr Moopens Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Abhishek R

Dr Moopens Medical College

研究点 (1)

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