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

NCT ID: NCT06166927

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-10

Study Completion Date

2026-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Cuffed endotracheal tube

Intervention Type DEVICE

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

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.

UnCuffed ETT

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hala Saad Abdel-Ghaffar. MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut university Pediatric hospital

Asyut, Assiut Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hala S Abdel-Ghaffar, MD

Role: CONTACT

01003812011 ext. +20

Hajer YA Moustafa, Master

Role: CONTACT

01148106632 ext. +20

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hala S Abdel-Ghaffar, MD

Role: primary

+2 01003812011

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

04-2023-200515

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ETT Cuff Leak: TV Ratios
NCT02768831 COMPLETED NA