[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658178":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":25,"armGroups":26,"interventions":21,"overallOfficials":21,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":21,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Samsun University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Oropharyngeal Leak Pressure","Oropharyngeal leak pressure (OLP) is measured in cm H2O after confirming proper Video LMA placement. With a fresh gas flow set at 6-8 L\u002Fmin, the expiratory (APL) valve is gradually closed, and OLP is recorded as the airway pressure at which an audible air leak is detected.","Intraoperatively",[14,18],{"measure":15,"description":16,"timeFrame":17},"Postoperative Sore Throat","The incidence and severity of postoperative sore throat reported by patients. Assessed using a standard 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe","Up to 24 hours postoperatively",{"measure":19,"description":20,"timeFrame":17},"Postoperative Dysphagia and Hoarseness","The presence and incidence of swallowing difficulty (dysphagia) and voice alteration (hoarseness) reported by patients.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","Adult patients scheduled to undergo elective tympanoplasty surgery under general anesthesia requiring supraglottic airway management with a Video LMA.",[27,30],{"label":28,"type":21,"description":29,"interventionNames":21},"Video LMA Cuff Pressure \u003C= 50 cm H2O","Patients undergoing tympanoplasty under general anesthesia in whom the Video LMA cuff pressure is measured at 50 cm H2O or lower. Oropharyngeal leak pressure is measured intraoperatively after visual confirmation of device position, and postoperative pharyngeal symptoms are monitored for the first 24 hours.",{"label":31,"type":21,"description":32,"interventionNames":21},"Video LMA Cuff Pressure > 50 cm H2O","Patients undergoing tympanoplasty under general anesthesia in whom the Video LMA cuff pressure is measured higher than 50 cm H2O. Oropharyngeal leak pressure is measured intraoperatively after visual confirmation of device position, and postoperative pharyngeal symptoms are monitored for the first 24 hours.",[34],{"name":35,"role":36,"phone":37,"phoneExt":21,"email":38},"R.Burak Ferli, MD","CONTACT","+90 542 645 92 95","rburakferli.md@gmail.com",[40],{"facility":41,"status":21,"city":42,"state":21,"zip":43,"country":44,"countryCode":21,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Samsun City Hospital","Samsun","55080","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],36.3361,41.27976,{"lat":49,"lon":48},[52],{"name":35,"role":36,"phone":37,"phoneExt":21,"email":38},{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100658178","effects-of-video-lma-cuff-pressure-in-tympanoplasty-100658178",false,"NCT07849322","Effects of Video LMA Cuff Pressure in Tympanoplasty.","The Effect of Video LMA Cuff Pressure on Oropharyngeal Leak Pressure in Tympanoplasty","Inclusion Criteria:\n\n* Scheduled for elective tympanoplasty under general anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-II-III\n* Aged between 18 and 75 years\n* Written informed consent obtained prior to surgery\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study\n* Illiterate patients\n* Patients unsuitable for laryngeal mask airway ventilation\n* Patients with preoperative sore throat\n* Patients who used NSAIDs within 24 hours prior to surgery\n* Patients diagnosed with gastroesophageal reflux\n* Patients with a history of oropharyngeal and\u002For head and neck surgery\n* Patients with ASA physical status IV\n* Patients with cognitive impairment or unable to cooperate\n* Patients diagnosed with psychiatric disorders (schizophrenia, mania, depression, etc.)\n* Patients using antipsychotic medication for longer than 4 weeks","ALL","18 Years","75 Years",{"count":66,"type":67},48,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the effects of different cuff pressure levels of the Video Laryngeal Mask Airway (Video LMA) on airway safety, ventilation efficacy, and postoperative pharyngeal symptoms in patients undergoing tympanoplasty surgery. Patients are evaluated in two groups based on the measured Video LMA cuff pressure: 50 cm H2O or lower, and higher than 50 cm H2O. The primary outcome is oropharyngeal leak pressure (OLP). Secondary outcomes include the incidence and severity of postoperative pharyngeal symptoms, such as sore throat, dysphagia, and hoarseness, assessed during the first 24 hours postoperatively. Video LMA provides visual confirmation of correct anatomical position, allowing the effects of cuff pressure to be evaluated independently of device malposition.",[10,71,72],"Airway Management","Postoperative Sore Throat, Cough, Hoarseness",[74,75,10],"Cuff Pressure","Video Laryngeal Mask Airway","NOT_YET_RECRUITING","2026-09-24",{"date":79,"type":80},"2026-09-30","ACTUAL",{"date":82,"type":67},"2026-09-25",{"date":84,"type":67},"2027-02-01",{"name":5,"class":6},1]