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Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel

Study acronym: SAFE-BCP
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Study completion date: Sep 15, 2026 to Aug 16, 2026
  2. Trial completed
    • Final enrollment: 80 participants (planned 70)
    • Eligibility criteria expanded, about 20 words
    • Site details revised
  3. Recruitment opened
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 performance of SafeLM™ video laryngeal mask airway and i-gel® supraglottic airway device in patients undergoing shoulder surgery in the beach chair position under general anesthesia. The primary objective is to evaluate oropharyngeal leak pressure (OLP) within the first 10 minutes after transition to the beach chair position. Secondary objectives include assessment of ventilation safety, need for airway interventions, and postoperative airway-related complications. This prospective randomized study will provide data on the effectiveness and safety of a video-guided supraglottic airway device compared to a conventional device in a clinically challenging position.
Trial Details
NCT Number NCT07501468
Lead Sponsor Ankara City Hospital Bilkent
Conditions
(from sponsor)		 Airway Management, Shoulder Surgery, General Anesthetic, Supraglottic Airway
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov