Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel
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
Ankara City Hospital Bilkent
70 participants
Apr 15, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria16
- 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
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Interventions
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.
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)
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NCT07501468