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NCT Number: NCT06166927

The Use of a US-measured Styloid Process of the Distal Radius EET Diameter for Prediction of ETT Size

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.

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Key information

Conditions

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

Location status: Recruiting

Location contact

Hala S Abdel-Ghaffar, MD

CONTACT

[email protected]

+2 01003812011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Cuffed endotracheal tube

Device

Patients will be intubated using a cuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.

Other names: Cuffed ETT

UnCuffed ETT

Device

Patients will be intubated using an uncuffed ETT (Flexicare-UK) with its OD determined by US measurement of the epiphyseal diameter of the distal radius.

Other names: Patients will be intubated using an uncuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hajer YA Moustafa, Master

CONTACT

[email protected]

01148106632 ext. +20

Hala S Abdel-Ghaffar, MD

CONTACT

[email protected]

01003812011 ext. +20

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: ETT/US

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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