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NCT Number: NCT07586592

Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing

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.

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Key information

Age range

3 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbasseya, 00202, Egypt

Location status: Recruiting

Location contact

Nouran Nemr, M.B.B.Ch, M.Sc.

CONTACT

[email protected]

01008558583

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Ultrasound

Device

Using Ultrasound for accuracy of ETT sizing

Cole's Formula

Other

Subglottic diameter in mm x 0.8

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of post-extubation stridor/croup

    Time frame: From extubation until 24 hours post-extubation

    Occurrence of post-extubation stridor or croup assessed using the Westley croup score.

  2. Severity of post-extubation croup

    Time frame: At 30 minutes, 2 hours, and 24 hours after extubation

    Severity of post-extubation croup assessed using the Westley croup score

  3. Duration of ICU stay related to airway complications

    Time frame: From ICU admission until ICU discharge, up to 30 days

    Length of ICU stay due to airway complications such as post-extubation stridor

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Tolba, MD

CONTACT

01156622298

Nouran Nemr, M.B.B.Ch, M.Sc.

CONTACT

[email protected]

01008558583

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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