Clinical Trial

Comparison of Gastric Volume Changes After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients

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Summary
This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 mL/kg is associated with a lower risk of perioperative aspiration. Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices. The primary objective of this study is to determine whether there is a difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-06-09
Trial Details
NCT Number NCT07555080
Lead Sponsor Istanbul University
Conditions Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children, Gastric Volume, Gastric Insufflation, Airway Complications
Enrollment 250 participants
Start Date 2026-06-15
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-08