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Recruiting NCT07586592

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

No phase Interventional Endotracheal Tube Wrongly Placed During Anesthetic Procedure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound, Cole's Formula.
Who it may be relevant to
Registry conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure. Basic parameters: 3 months — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device Ultrasound
    Using Ultrasound for accuracy of ETT sizing
  • Other Cole's Formula
    Subglottic diameter in mm x 0.8

Primary outcome measures

  • Accuracy of ETT size selection [Time frame: During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT07586592 · FMASU MD353/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗