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

ConditionEndotracheal Tube Wrongly Placed During Anesthetic Procedure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Refusal of legal guardians

Emergency surgery

Patients with tracheostomy tubes

Recent or active upper respiratory tract infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound

    Device

    Using Ultrasound for accuracy of ETT sizing

  • Cole's Formula

    Other intervention

    Subglottic diameter in mm x 0.8

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Age-Based Formula GroupActive comparator 1 intervention
Group B: Ultrasound GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)

Secondary outcomes

1

Incidence of post-extubation stridor/croup

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

Time frame
From extubation until 24 hours post-extubation
2

Severity of post-extubation croup

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

Time frame
At 30 minutes, 2 hours, and 24 hours after extubation
3

Duration of ICU stay related to airway complications

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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