Clinical Trial

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

Study acronym: SAFE-BCP
Recruiting
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Record status
This record was last updated July 14, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-15
Trial Details
NCT Number NCT07501468
Lead Sponsor Ankara City Hospital Bilkent
Conditions Airway Management, Shoulder Surgery, General Anesthetic, Supraglottic Airway
Enrollment 70 participants
Start Date 2026-04-15
Primary Completion 2026-08-15 (estimated)
Study Completion 2026-09-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-14