Ain Shams University
Cairo, Abbasseya, 00202, Egypt
Location status: Recruiting
NCT Number: NCT07586592
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.
Interested in participating?
Request Info3 month–8 year
All sexes
Interventional
Not applicable
Cairo, Abbasseya, 00202, Egypt
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using Ultrasound for accuracy of ETT sizing
Subglottic diameter in mm x 0.8
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.
Time frame: From extubation until 24 hours post-extubation
Occurrence of post-extubation stridor or croup assessed using the Westley croup score.
Time frame: At 30 minutes, 2 hours, and 24 hours after extubation
Severity of post-extubation croup assessed using the Westley croup score
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
Contact information is provided by the study sponsor or research team.
Mohamed Tolba, MD
CONTACT
Nouran Nemr, M.B.B.Ch, M.Sc.
CONTACT
Ain Shams University
Other
Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients
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.
Published trials that share one or more normalized conditions with this study.
NCT04216199
Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Tanta, Egypt
View Trial DetailsNCT02691468
Endotracheal Tube Wrongly Placed During Anesthetic Procedure, Surgical Procedure, Unspecified
Daegu, South Korea
View Trial DetailsNCT03929445
Endotracheal Tube Wrongly Placed During Anesthetic Procedure, Intubation;Difficult
Cairo, Egypt
View Trial DetailsNCT01373437
Disease Attributes, Emergencies
Bangkok, Thailand
View Trial Details