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

Airway Management Clinical Trial

— ETT/US  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166927
• Other study ID #: 04-2023-200515
• Status: Recruiting
• Start date: January 10, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Hala S Abdel-Ghaffar, MD
• Phone: 01003812011
• Email: hallasaad[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2025
• Est. primary completion date: January 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Cuffed endotracheal tube
Patients will be intubated using a cuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.
• UnCuffed ETT
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.

Locations

Country	Name	City	State
Egypt	Assiut university Pediatric hospital	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between the reference tube size based on US- Epiphyseal Diameter of distal radius measured OD and the final BFT	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.	At induction of anesthesia