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

NCT06166927 | Recruiting DMC FDA Device

• 1 other identifier: 04-2023-200515
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

Children, airway, ETT, US, radial diameter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Device: Cuffed endotracheal tube

Uncuffed Endotracheal tube.

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

Device: UnCuffed ETT

Interventions

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.

Also known as: Cuffed ETT

Cuffed Endotracheal tube.

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.

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

Uncuffed Endotracheal tube.

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 1-6 years of both sexes undergoing surgical procedures in which an endotracheal tube is needed.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university Pediatric hospital

Asyut, Assiut Governorate, 715715, Egypt

RECRUITING

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdel-Ghaffar, MD

CONTACT

01003812011; hallasaad@yahoo.com

Hajer YA Moustafa, Master

CONTACT

01148106632; Hajeryasser304@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: January 10, 2024
• Primary Completion: January 20, 2026
• Study Completion: January 30, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)