[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631498":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Ankara City Hospital Bilkent","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SafeLM Group","EXPERIMENTAL","Participants randomized to this arm will receive airway management using the SafeLM™ video laryngeal mask airway during general anesthesia for shoulder surgery in the beach chair position.",[13],"Device: SafeLM™ video laryngeal mask airway",{"label":15,"type":16,"description":17,"interventionNames":18},"i-gel Group","ACTIVE_COMPARATOR","Participants randomized to this arm will receive airway management using the i-gel® supraglottic airway device during general anesthesia for shoulder surgery in the beach chair position.",[19],"Device: i-gel® supraglottic airway device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Sündüz İlayda Yıldız Akça, MD","CONTACT","+905076111649","sunduzilayda@hotmail.com",[38],{"facility":39,"status":26,"city":40,"state":40,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Ankara Bilkent City Hospital","Ankara","06800","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],32.85427,39.91987,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":51,"phoneExt":26,"email":36},"+905352501649",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","semih başkan","Principal Investigator","100631498","ventilation-safety-in-beach-chair-shoulder-surgery-safelm-versus-i-gel-100631498",false,"NCT07501468","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","SAFE-BCP","Inclusion Criteria:\n\n* Patients aged 18-80 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Scheduled for elective shoulder surgery\n* Body mass index (BMI) between 18-40 kg\u002Fm\\^2\n* Adequate preoperative fasting (approximately 8 hours)\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>80 years\n* Refusal to participate\n* ASA physical status \\>= IV\n* BMI \\>40 kg\u002Fm\\^2\n* Failure of supraglottic airway device placement after three attempts\n* Revision surgery\n* Multiple trauma\n* Maxillofacial fracture\n* Active malignancy receiving radiotherapy or chemotherapy\n* Active infection or ongoing antibiotic therapy (except prophylaxis)\n* Chronic steroid or immunosuppressive therapy\n* Full stomach\n* Gastroesophageal reflux disease\n* History of gastric surgery\n* Gastroparesis\n* Known egg allergy","ALL","18 Years","80 Years",{"count":68,"type":69},70,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.",[75,76,77,78],"Airway Management","Shoulder Surgery","General Anesthetic","Supraglottic Airway",[80,81,82,83,84,85],"Oropharyngeal Leak Pressure","SafeLM","i-gel","Ventilation Safety","Beach Chair Position","Video Laryngeal Mask Airway","NOT_YET_RECRUITING","2026-03-26",{"date":89,"type":90},"2026-03-30","ACTUAL",{"date":92,"type":69},"2026-04-15",{"date":94,"type":69},"2026-09-15",{"name":5,"class":6},1]