Airway ManagementETT/USNCT06166927
The Use of a US-measured Styloid Process of the Distal Radius EET Diameter for Prediction of ETT Size
An observational study of Airway Management, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Cuffed endotracheal tube and UnCuffed ETT
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 30 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 1-6 years of both sexes undergoing surgical procedures in which an endotracheal tube is needed.
Who may be able to join
- 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.
Who cannot join
- Upper airway malformations.
- Upper airway surgery.
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
- Anticipated difficult airway.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university Pediatric hospital
Asyut, Assiut Governorate, 715715
Hala S Abdel-Ghaffar, MD, +2 01003812011, hallasaad@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Airway Management
- Being tested
- Cuffed endotracheal tube, UnCuffed ETT
- Keywords
- Children, airway, ETT, US, radial diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cuffed endotracheal tubeDevice
Also called Cuffed ETT
Patients will be intubated using a cuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.
UnCuffed ETTDevice
Also called Patients will be intubated using an uncuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: UnCuffed ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start10 Jan 2024
- Primary completion20 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar. MD, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166927
- Sponsor's protocol ID
- 04-2023-200515
- Acronym
- ETT/US
- Status last verified
- Mar 2025
- First submitted
- 4 Dec 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06166927
- Acronym / sponsor ID
- ETT/US / 04-2023-200515
- Conditions
- Airway Management
- Keywords
- Children, airway, ETT, US, radial diameter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cuffed Endotracheal tube. | – | Device: Cuffed endotracheal tubePatients 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. | – | Device: UnCuffed ETTPatients will be intubated using an uncuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 1-6 years of both sexes undergoing surgical procedures in which an endotracheal tube is needed.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Upper airway malformations.
- Upper airway surgery.
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
- Anticipated difficult airway.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cuffed endotracheal tubeAlso: Cuffed ETTPatients will be intubated using a cuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius. | Device | Cuffed Endotracheal tube. |
| UnCuffed ETTAlso: Patients will be intubated using an uncuffed ETT with its OD determined by US measurement of the epiphyseal diameter of the distal radius.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. | Device | Uncuffed Endotracheal tube. |
Primary outcome
Agreement between the reference tube size based on US- Epiphyseal Diameter of distal radius measured OD and the final BFT
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hala S Abdel-Ghaffar, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Management, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala S Abdel-Ghaffar, MD (01003812011 ext. +20, hallasaad@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the reference tube size based on US- Epiphyseal Diameter of distal radius measured OD and the final BFT (time frame: At induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.