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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Airway Management
• Intervention / Treatment: Device: Cuffed endotracheal tube; Device: UnCuffed ETT

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Hala S Abdel-Ghaffar, MD; Phone Number: +20 01003812011; Email: hallasaad@yahoo.com
• Study Contact Backup: Name: Hajer YA Moustafa, Master; Phone Number: +20 01148106632; Email: Hajeryasser304@gmail.com

Study Locations

• Egypt
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, 715715
      • Recruiting
      • Assiut university Pediatric hospital
      • Contact: Hala S Abdel-Ghaffar, MD; Phone Number: +2 01003812011; Email: hallasaad@yahoo.com
      • Contact: Hala M Abdelaal, MBBCH; Phone Number: 01064222749; Email: hm3774218@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): January 20, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Children, airway, ETT, US, radial diameter
• Other Study ID Numbers: 04-2023-200515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No