跳至主要内容
临床试验/CTRI/2024/07/070585
CTRI/2024/07/070585尚未招募不适用

Clinical accuracy of ultrasonography to predict the size of endotracheal tube in neonates: an observational study

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Proportion of patients in which ultrasonography is clinically accurate to determine the best fit (air leak test) endotracheal tube

研究概览

简要总结

Endotracheal tube (ETT) is the definitive method for the management of airway during

general anaesthesia in neonates undergoing surgery. Conventionally, ETT size in neonates is

selected according to the gestational age and weight. However, these criteria are not always

accurate to estimate the correct ETT size and multiple trials of intubation and tube changes

may be required to place an appropriate size ETT. This may cause hypoxia and may also lead

to airway mucosal edema. An inappropriately sized ETT can lead to morbidity as large ETT

can cause airway damage and injury, subglottic edema, post extubation stridor, local

ischemia, scar formation and subglottic stenosis after a prolonged duration of intubation.

A smaller sized ETT will lead to higher leaks and thus, insufficient ventilation, high airway

resistance, poor monitoring of end-tidal gases and higher risk of aspiration and thus, lung

infections. Therefore, it is essential to determine the appropriate size of ETT for each patient

at the first attempt.

Ultrasonography (USG) is a safe and reliable modality which allows for a real time

and non-invasive assessment of the airway and subglottic area for estimation of ETT size,

thereby reducing the associated complications associated with an incorrect size ETT. This

study therefore, aims to determine the accuracy of USG to predict the size of endotracheal

tubes in neonates.

Multiple studies have been done for estimating the appropriate size of ETT in paediatric

population using ultrasonography. However, there is limited published literature related to

determining the ETT size by ultrasonography in neonates.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates undergoing general anaesthesia requiring endotracheal intubation.

排除标准

  • Anatomical deformity of upper airway
  • Presence of mass, scar or ulcer in the neck
  • Hemodynamically unstable patient requiring urgent intubation.

结局指标

主要结局

Proportion of patients in which ultrasonography is clinically accurate to determine the best fit (air leak test) endotracheal tube

时间窗: After performing the air leak test after intubation

次要结局

未报告次要终点

研究者

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

Dr Ananya Singh

Lady Hardinge Medical College

研究点 (1)

Loading locations...

相似试验