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

NCT07501468 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-14

No results posted yet for this study

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.

Conditions

  • Airway Management
  • Shoulder Surgery
  • General Anesthetic
  • Supraglottic Airway

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.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-08-15
Completion
2026-09-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501468 on ClinicalTrials.gov