Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel (NCT07501468) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel
Turkey (Türkiye)70 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Immediately after airway device placement in the supine position and 5 minutes after transition to the beach chair position during surgery