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

NCT07501468 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ankara City Hospital Bilkent

Phase

Not applicable

Started

2026-04-15

Last updated

2026-07-14

Condition(s) studied

Airway ManagementShoulder SurgeryGeneral AnestheticSupraglottic Airway

Investigational drug(s) / intervention(s)

SafeLM™ video laryngeal mask airwayi-gel® supraglottic airway 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.

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Patients aged 18-80 years * American Society of Anesthesiologists (ASA) physical status I-III * Scheduled for elective shoulder surgery * Body mass index (BMI) between 18-40 kg/m\^2 * Adequate preoperative fasting (approximately 8 hours) * Ability and willingness to provide written informed consent Exclusion Criteria: * Age \<18 or \>80 years * Refusal to participate * ASA physical status \>= IV * BMI \>40 kg/m\^2 * Failure of supraglottic airway device placement after three attempts * Revision surgery * Multiple trauma * Maxillofacial fracture * Active malignancy receiving radiotherapy or chemotherapy * Active infection or ongoing antibiotic therapy (except prophylaxis) * Chronic steroid or immunosuppressive therapy * Full stomach * Gastroesophageal reflux disease * History of gastric surgery * Gastroparesis * Known egg allergy

Primary outcome measure(s)

Oropharyngeal leak pressure (OLP) at two predefined time points: immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position — Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery
Comparison of oropharyngeal leak pressure (OLP) values measured immediately after insertion of the supraglottic airway device in the supine position and 5 minutes after transition to the beach chair position, as an indicator of airway sealing performance and ventilation safety.

Trial sites (1)

Facility	City	Region	Status
Ankara Bilkent City Hospital	Ankara	Ankara	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07501468 on ClinicalTrials.gov ↗ ← All trials in Turkey