Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT07586592
Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing
A study testing Ultrasound and Cole's Formula in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining the optimal endotracheal tube (ETT) size in pediatric patients with single ventricle physiology and reducing post-extubation complications. Read more about this study
- Who is it for?
- Ages 3 months to 8 years
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Ultrasound and Cole's Formula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 30 Jun 2027
- Phase
- Interventional
- 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 3 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients (3 months to 8 years)
- Patients with single ventricle physiology
- Scheduled for Glenn or Fontan surgery or cardiac catheterization
- Patients with Glenn or Fontan shunt scheduled for surgery
Who cannot join
- Refusal of legal guardians
- Emergency surgery
- Patients with tracheostomy tubes
- Recent or active upper respiratory tract infection
- Airway anomalies (e.g. Pierre Robin, Treacher Collins)
- ICU stay due to complications other than that of airway
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Tolba, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Abbasseya, 00202
Nouran Nemr, M.B.B.Ch, M.Sc., 01008558583, Nourannemr@med.asu.edu.eg
About this study
Official title: Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining the optimal endotracheal tube (ETT) size in pediatric patients with single ventricle physiology and reducing post-extubation complications.
Read the detailed description
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining optimal ETT size in pediatric patients with single ventricle physiology to avoid post-extubation complications. All legal guardians will provide written informed consent after a full explanation of the study. During the pre-anesthetic evaluation, demographic data, ASA physical status, relevant comorbidities, and a recent echocardiogram confirming single ventricle physiology will be documented. In the operating room, patients will be monitored using standard ASA monitors including ECG, non-invasive blood pressure, pulse oximetry, and capnography, followed by preoxygenation with 100% oxygen. If intravenous access is available, anesthesia will be induced with ketamine, fentanyl, and rocuronium. If IV access is not available, inhalational induction with sevoflurane will be used until IV access is secured, after which fentanyl and rocuronium will be administered. Following induction, ventilation will continue with FiO₂ 100% and sevoflurane 1.5% for 3 minutes.
Patients will be divided into two groups:
Group A (Age-Based Formula):
In neonates and infants under 1 year, a weight-based sizing is used:
- Infants <1 kg (Preterm): 2.5 mm ETT
- Infants 1-2 kg: 3 mm ETT
- Infants 2-3 kg (Full Term): 3-3.5 mm ETT
- Infants >3 kg (3 months to 1 year): 3.5-4 mm ETT
In Infants > 1 year, ETT size will be selected based on the standard formula: Cole's Formula for uncuffed ETT.
ETT ID (mm) = (Age/4) + 4.
Group B (Ultrasound Group):
During mask ventilation, a trained anesthesiologist will perform transverse subglottic diameter measurement using a high-frequency linear ultrasound probe (7-15 MHz). The patient will be positioned supine with mild neck extension. The probe will be placed transversely just below the thyroid cartilage to identify the subglottic airway at the level of the cricoid cartilage. The measured diameter (in mm) will be recorded and used to determine ETT size from the equation:
ETT ID (mm) = Subglottic diameter (mm) × 0.8 To confirm appropriate ETT sizing, all patients will be placed on pressure-controlled mechanical ventilation and a leak test will be performed in both groups. Start with pressure 20-25 cm H₂O, if there is resistance to ETT passage into the trachea or no audible leak or ventilator-detected leak when the lungs are inflated, the tube will be exchanged for one that is 0.5 mm smaller. If a leak is detected, decrease the pressure to 10 cm H₂O. If there's still a detected leak at 10 cm H₂O, the ETT will be exchanged for one that is 0.5 mm larger. If there's no leak at 10 cm H₂O then the ETT is optimal. Tube size will be considered optimal when a tracheal leak is not detected at an inflation pressure between 10-20 cm H₂O with uncuffed tubes.
- Being tested
- Ultrasound, Cole's Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Using Ultrasound for accuracy of ETT sizing
Cole's FormulaOther
Subglottic diameter in mm x 0.8
| Study group | Role | What they receive |
|---|---|---|
| Age-Based Formula Group | Active comparator | In neonates and infants under 1 year, a weight-based sizing is used:
* Infants <1 kg (Preterm): 2.5 mm ETT
* Infants 1-2 kg: 3 mm ETT
* Infants 2-3 kg (Full Term): 3 - 3.5 mm ETT
* Infants >3 kg (3 months to 1 year): 3.5 - 4 mm ETT In Infants > 1 year, ETT size will be selected based on the standard formula: Cole's Formula for uncuffed ETT.
ETT ID (mm) = (Age/4) + 4. Receives: Other: Cole's Formula |
| Ultrasound Group | Active comparator | During mask ventilation, a trained anesthesiologist will perform transverse subglottic diameter measurement using a high-frequency linear ultrasound probe (7-15 MHz). The patient will be positioned supine with mild neck extension. The probe will be placed transversely just below the thyroid cartilage to identify the subglottic airway at the level of the cricoid cartilage. The measured diameter (in mm) will be recorded and used to determine ETT size from the equation:
ETT ID (mm) = Subglottic diameter (mm) × 0.8 Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ETT size selection
Accuracy of endotracheal tube size selection measured by the number of ETT attempts required to achieve an appropriate leak test and successful airway placement.
Measured: During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)
Secondary outcomes (3)
Incidence of post-extubation stridor/croup
Occurrence of post-extubation stridor or croup assessed using the Westley croup score.
Measured: From extubation until 24 hours post-extubation
Severity of post-extubation croup
Severity of post-extubation croup assessed using the Westley croup score
Measured: At 30 minutes, 2 hours, and 24 hours after extubation
Duration of ICU stay related to airway complications
Length of ICU stay due to airway complications such as post-extubation stridor
Measured: From ICU admission until ICU discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Wrongly Placed During Anesthetic ProcedureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586592
- Sponsor's protocol ID
- FMASU MD353/2025
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients
- ClinicalTrials.gov ID
- NCT07586592
- Acronym / sponsor ID
- FMASU MD353/2025
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 May 2026 (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.
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining the optimal endotracheal tube (ETT) size in pediatric patients with single ventricle physiology and reducing post-extubation complications.
Detailed description
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining optimal ETT size in pediatric patients with single ventricle physiology to avoid post-extubation complications. All legal guardians will provide written informed consent after a full explanation of the study. During the pre-anesthetic evaluation, demographic data, ASA physical status, relevant comorbidities, and a recent echocardiogram confirming single ventricle physiology will be documented. In the operating room, patients will be monitored using standard ASA monitors including ECG, non-invasive blood pressure, pulse oximetry, and capnography, followed by preoxygenation with 100% oxygen. If intravenous access is available, anesthesia will be induced with ketamine, fentanyl, and rocuronium. If IV access is not available, inhalational induction with sevoflurane will be used until IV access is secured, after which fentanyl and rocuronium will be administered. Following induction, ventilation will continue with FiO₂ 100% and sevoflurane 1.5% for 3 minutes.
Patients will be divided into two groups:
Group A (Age-Based Formula):
In neonates and infants under 1 year, a weight-based sizing is used:
- Infants <1 kg (Preterm): 2.5 mm ETT
- Infants 1-2 kg: 3 mm ETT
- Infants 2-3 kg (Full Term): 3-3.5 mm ETT
- Infants >3 kg (3 months to 1 year): 3.5-4 mm ETT
In Infants > 1 year, ETT size will be selected based on the standard formula: Cole's Formula for uncuffed ETT.
ETT ID (mm) = (Age/4) + 4.
Group B (Ultrasound Group):
During mask ventilation, a trained anesthesiologist will perform transverse subglottic diameter measurement using a high-frequency linear ultrasound probe (7-15 MHz). The patient will be positioned supine with mild neck extension. The probe will be placed transversely just below the thyroid cartilage to identify the subglottic airway at the level of the cricoid cartilage. The measured diameter (in mm) will be recorded and used to determine ETT size from the equation:
ETT ID (mm) = Subglottic diameter (mm) × 0.8 To confirm appropriate ETT sizing, all patients will be placed on pressure-controlled mechanical ventilation and a leak test will be performed in both groups. Start with pressure 20-25 cm H₂O, if there is resistance to ETT passage into the trachea or no audible leak or ventilator-detected leak when the lungs are inflated, the tube will be exchanged for one that is 0.5 mm smaller. If a leak is detected, decrease the pressure to 10 cm H₂O. If there's still a detected leak at 10 cm H₂O, the ETT will be exchanged for one that is 0.5 mm larger. If there's no leak at 10 cm H₂O then the ETT is optimal. Tube size will be considered optimal when a tracheal leak is not detected at an inflation pressure between 10-20 cm H₂O with uncuffed tubes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age-Based Formula Group | Active comparator | Other: Cole's FormulaIn neonates and infants under 1 year, a weight-based sizing is used: * Infants <1 kg (Preterm): 2.5 mm ETT * Infants 1-2 kg: 3 mm ETT * Infants 2-3 kg (Full Term): 3 - 3.5 mm ETT * Infants >3 kg (3 months to 1 year): 3.5 - 4 mm ETT In Infants > 1 year, ETT size will be selected based on the standard formula: Cole's Formula for uncuffed ETT. ETT ID (mm) = (Age/4) + 4. |
| Ultrasound Group | Active comparator | Device: UltrasoundDuring mask ventilation, a trained anesthesiologist will perform transverse subglottic diameter measurement using a high-frequency linear ultrasound probe (7-15 MHz). The patient will be positioned supine with mild neck extension. The probe will be placed transversely just below the thyroid cartilage to identify the subglottic airway at the level of the cricoid cartilage. The measured diameter (in mm) will be recorded and used to determine ETT size from the equation: ETT ID (mm) = Subglottic diameter (mm) × 0.8 |
Who may qualify
- Ages
- 3 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients (3 months to 8 years)
- Patients with single ventricle physiology
- Scheduled for Glenn or Fontan surgery or cardiac catheterization
- Patients with Glenn or Fontan shunt scheduled for surgery
Key exclusion criteria (6 listed)
- Refusal of legal guardians
- Emergency surgery
- Patients with tracheostomy tubes
- Recent or active upper respiratory tract infection
- Airway anomalies (e.g. Pierre Robin, Treacher Collins)
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 |
|---|---|---|
| UltrasoundUsing Ultrasound for accuracy of ETT sizing | Device | Ultrasound Group |
| Cole's FormulaSubglottic diameter in mm x 0.8 | Other | Age-Based Formula Group |
Primary outcome
Accuracy of ETT size selection
Time frame: During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)
Accuracy of endotracheal tube size selection measured by the number of ETT attempts required to achieve an appropriate leak test and successful airway placement.
3 secondary outcomes
Incidence of post-extubation stridor/croup
Time frame: From extubation until 24 hours post-extubation
Severity of post-extubation croup
Time frame: At 30 minutes, 2 hours, and 24 hours after extubation
Duration of ICU stay related to airway complications
Time frame: From ICU admission until ICU discharge, up to 30 days
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 14 May 2026.
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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.
Mohamed Tolba, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and Cole's Formula in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Ain Shams 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 4 inclusion and 6 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 14 May 2026. 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 Nouran Nemr, M.B.B.Ch, M.Sc. (01008558583, Nourannemr@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ETT size selection (time frame: During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)). 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 14 May 2026.