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Ultrasonographic Subglottic Airway Measurements and Postoperative Respiratory Events in Young Children

StatusTerminated
PhaseNot specified
Started
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Record History

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  1. Reclassified as terminated (was completed) Sponsor's reason: Recruitment was stopped earlier than initially planned following an investigator decision that the available sample was sufficient for exploratory analysis. A total of 139 participants were enrolled, compared with the initially estimated 350. Show 4 more changesShow less
    • Primary endpoint revised
    • Secondary endpoint revised
    • Study site revised
    • Publications: details revised at 2 of 2 entries
  2. Primary endpoint(s) modified Show 10 more changesShow less
    • Completed without a posted recruiting period
    • Final enrollment: 139 participants (planned 350)
    • Primary completion date changed from estimate of Feb 1, 2027 to Jun 30, 2026
    • Interventions modified
    • Start date changed from estimate of Feb 1, 2026 to Mar 1, 2026
    • Eligibility criteria shortened, about 16 words
    • Secondary endpoint revised
    • Study description expanded, about 109 words
    • Site contact updated
    • Publications: details revised at 2 of 2 entries
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 better understand airway-related respiratory events that may occur in children under three years of age undergoing general anesthesia with a laryngeal mask airway (LMA). As part of the study, ultrasonographic measurements of the subglottic airway will be performed at different time points during anesthesia using a non-invasive ultrasound device. Changes in these measurements will be evaluated in relation to intervention-requiring upper-airway events occurring during anesthesia, LMA removal, or early recovery. The results may contribute to a better understanding of airway-related factors associated with respiratory events in young children undergoing anesthesia with an LMA.
Trial Details
NCT Number NCT07394686
Lead Sponsor Bursa Sevket Yilmaz Training and Research Hospital
Conditions
(from sponsor)		 Perioperative Respiratory Adverse Events, Postoperative Respiratory Complications
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov