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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07586592
Enrollment
60
Registered
2026-05-14
Start date
2026-01-01
Completion date
2027-06-30
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Brief 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.

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

DEVICEUltrasound

Using Ultrasound for accuracy of ETT sizing

OTHERCole's Formula

Subglottic diameter in mm x 0.8

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of ETT size selectionDuring 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

MeasureTime frameDescription
Incidence of post-extubation stridor/croupFrom extubation until 24 hours post-extubationOccurrence of post-extubation stridor or croup assessed using the Westley croup score.
Severity of post-extubation croupAt 30 minutes, 2 hours, and 24 hours after extubationSeverity of post-extubation croup assessed using the Westley croup score
Duration of ICU stay related to airway complicationsFrom ICU admission until ICU discharge, up to 30 daysLength of ICU stay due to airway complications such as post-extubation stridor

Countries

Egypt

Contacts

CONTACTNouran Nemr, M.B.B.Ch, M.Sc.
Nourannemr@med.asu.edu.eg01008558583
CONTACTMohamed Tolba, MD
01156622298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026