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临床试验/NCT06166927
NCT06166927招募中不适用

The Correlation Between Ultrasound-measured Styloid Process of the Distal Radius and the Outer Diameter of the Best-fitting Endotracheal Tube in Pediatrics

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Agreement between the reference tube size based on US- Epiphyseal Diameter of distal radius measured OD and the final BFT

研究概览

简要总结

This study will aim to test the accuracy of the ultrasonography measurement of the epiphyseal diameter of the distal radius in the prediction of the size of the cuffed and uncuffed ETT that best fits in children (1-6 years old) in comparison with the traditional age-based formulas.

详细描述

Various formulas are used to predict the inner diameter (ID) of the ETT tube whether uncuffed or cuffed based on weight, age, height, and finger size. The accuracy of these formulas is questionable. These formulas depend on the child's demographic characteristics assuming that he/she has normal growth and development and cannot be applied to children with altered growth and development. Moreover, these formulas predict the ID of the ETT ignoring the tube thickness and the OD of the selected tube.

ultrasound has recently been identified as an accurate alternative to these formulas. The US-measured epiphyseal diameter of the distal radius is a method that has been recently introduced as a surrogate for the tracheal diameter. The issue is that the size of the airway can be considered a reflection of the body's growth, assuming that the growth rates of the cartilage all over the body are closely related to each other. Therefore, the measurement of the growth of the bony cartilage of the hand can be considered a surrogate marker of the tracheal diameter.9 The extent to which ultrasonography by this method can succeed in predicting the optimal pediatric ETT size remains under investigation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Weight: 10-30 kg.
  • Age: 1-6 years.
  • Sex: both males and females.
  • ASA physical status: I-II.
  • Operation: elective surgery in which airway management with an endotracheal tube is needed.

排除标准

  • Upper airway malformations.
  • Upper airway surgery.
  • Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
  • Anticipated difficult airway.

结局指标

主要结局

Agreement between the reference tube size based on US- Epiphyseal Diameter of distal radius measured OD and the final BFT

时间窗: At induction of anesthesia

The US probe will be first placed longitudinally over the distal radius to identify the epiphysis. Then the probe will be turned 90 degrees to identify and measure the transverse diameter of the radius epiphysis. These measured diameters coincide with the OD of the ETT.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hala Saad Abdel-Ghaffar. MD

Professor

Assiut University

研究点 (1)

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