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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Primary completion date changed from estimate of Aug 2026 to Aug 20, 2026
    • Eligibility criteria expanded, about 10 words
    • Study description revised
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  2. Notable Primary endpoint(s) modifiedv2 Show 5 more changesShow less
    • Start date: May 2026 to Jun 15, 2026
    • Secondary endpoints revised (8)
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 2 words
    • Study title shortened, about 2 words
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07555080
Lead Sponsor Istanbul University
Conditions
(from sponsor)
Gastric Ultrasonography, Supraglottic Airways, Supraglottic Airway Use in Children, Gastric Volume, Gastric Insufflation, Airway Complications
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov