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NOT YET RECRUITING
NCT07501468
NA

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

Sponsor: Ankara City Hospital Bilkent

View on ClinicalTrials.gov

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.

Official title: Comparison of SafeLM™ Video Laryngeal Mask and I-gel® for Ventilation Safety After Transition to Beach Chair Position in Patients Undergoing Shoulder Surgery: A Prospective Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-04-15

Completion Date

2026-09-15

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DEVICE

SafeLM™ video laryngeal mask airway

A video-guided supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position. It allows real-time visualization of glottic structures during placement.

DEVICE

i-gel® supraglottic airway device

A second-generation supraglottic airway device used for airway management during general anesthesia in patients undergoing shoulder surgery in the beach chair position.

Locations (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Turkey (Türkiye)