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

Recruiting

• Conditions: Airway Management
• Interventions: Device: Cuffed endotracheal tube; Device: UnCuffed ETT

• Registration Number: NCT06166927
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-12
• Study Start: 2024-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-01-20
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cuffed Endotracheal tube.	Cuffed endotracheal tube	Patients will be intubated using a high-volume low-pressure cuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.
Uncuffed Endotracheal tube.	UnCuffed ETT	Patients will be intubated using an uncuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assiut university Pediatric hospital; 🇪🇬 Assiut, Assiut Governorate, Egypt