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临床试验/CTRI/2024/04/065299
CTRI/2024/04/065299尚未招募3 期

Age based motoyama formula versus ultrasound guided subglottic diameter in predicting endotracheal tube size in pediatric population - A Prospective Comparative Study

RAJASEKAR MG1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Leak Test

研究概览

简要总结

This prospective comparative study, led by Dr. MG Rajasekar, aims to evaluate the effectiveness of age-based Motoyama formula versus ultrasound-guided subglottic diameter in predicting the correct endotracheal tube (ETT) size in the pediatric population. The primary objective involves identifying appropriate ETT size by the leak test, with secondary objectives including assessing airway pressure, intubation attempts, and postoperative complications.The study plans to enroll 70 pediatric patients.After the pre-anesthetic assessment, patients are randomized into two groups for intubation. Group B uses the Motoyama age-based formula for endotracheal tube (ETT) size calculation, while Group A employs high-resolution ultrasonography to assess subglottic diameter. Both groups undergo standard anesthesia induction and maintenance, with ETT leak tests performed to ensure correct sizing. Airway pressure is monitored, and neuromuscular blockade is managed. Post-surgery, complications such as cough, blood staining, and stridor incidence are observed.Total number of clinically fit and unfit will be calculated by the leak test and number of times ETT changed will be documented.Statistical analysis will employ IBM SPSS version 20.0, with significance set at p-value < 0.05. The study is scheduled from April 2024 to September 2025 at Apollo KH Hospital, Melvisharam.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Patients parent/guardian willing to give informed written consent
  • American society of Anaesthesiologist (ASA) class 1,class 2
  • Age group 5-12 years
  • 85th percentiles]
  • Patients undergoing various elective surgery under general anaesthesia and requiring endotracheal intubation.

排除标准

  • 1.Preexisting laryngeal or tracheal pathology
  • Patients with facial abnormalities 3.Anticipated difficult airway 4.Patients having respiratory tract infections 5.Emergency surgery.

结局指标

主要结局

Leak Test

时间窗: Immediately after the intubation

次要结局

  • 1.Airway pressure(2.Number of times the child was intubated)

研究者

发起方
RAJASEKAR MG
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rajasekar MG

Apollo KH Hospital

研究点 (1)

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