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NCT07501468
Ventilation Safety in Beach Chair Shoulder Surgery: SafeLM Versus I-gel
Conditions: Airway Management, Shoulder Surgery, General Anesthetic, Supraglottic Airway
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Ankara City Hospital Bilkent
Location: Ankara Bilkent City Hospital Ankara Ankara
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 Criteria
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 \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
Source: ClinicalTrials.gov (NCT07501468). StuddyBuddy aggregates publicly available trial information.