[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626014":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":50,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":30,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Ankara Etlik City Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FCV Group","ACTIVE_COMPARATOR","Patients allocated to the FCV group will receive intraoperative mechanical ventilation using a flow-controlled ventilation mode during surgery under general anesthesia. 80-100% FiO₂ will be applied, and a driving pressure of 12 cmH₂O will be used. After the 20th minute, the patient's FiO₂ will be adjusted according to the clinical condition.\n\nTidal volume will be generated and recorded by the ventilator according to the driving pressure and the patient's lung mechanics.\n\nMinute ventilation will be adjusted based on the target tidal volume. The target tidal volume will be set at 6-8 mL\u002Fkg (7 mL\u002Fkg) with a respiratory rate of 12 breaths\u002Fmin.\n\nPositive end-expiratory pressure (PEEP) will be maintained at 5 cmH₂O. The respiratory rate was further titrated to maintain ETCO₂ between 35 and 40 mmHg.",[13],"Procedure: FCV Group",{"label":15,"type":10,"description":16,"interventionNames":17},"VCV Group","Patients allocated to the VCV group will receive intraoperative mechanical ventilation using a conventional volume-controlled ventilation mode throughout surgery under general anesthesia. Patients will be started on ventilation after intubation with 80-100% FiO₂, 7 ml\u002Fideal body weight tidal volume, PEEP 5, 12 breaths per minute frequency, and a 1:2 inspiration\u002Fexpiration ratio. After the 20th minute, the patient's FiO₂ will be adjusted according to the clinical condition.",[18],"Procedure: VCV Group",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Patients allocated to the FCV group will receive mechanical ventilation using a flow-controlled ventilation mode throughout the surgical procedure performed under general anesthesia. Ventilation will be managed according to routine clinical practice, with standardized anesthetic induction and monitoring. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points, including after starting the ventilation under general anesthesia and 20 minutes after intubation. This group aims to evaluate the effects of FCV on airway pressures and early intraoperative oxygenation during balloon dilatation performed under direct laryngoscopy.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Patients allocated to the VCV group will receive mechanical ventilation using a conventional volume-controlled ventilation mode throughout the surgical procedure under general anesthesia. Anesthetic management and monitoring will follow standard clinical protocols identical to those applied in the FCV group. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas measurements will be recorded at the same predefined intraoperative time points, including after starting the ventilation under general anesthesia and 20 minutes after intubation. This group serves as the comparator arm to assess the effects of volume-controlled ventilation on airway pressures and oxygenation during balloon dilatation under direct laryngoscopy.",[15],[29],{"facility":5,"status":30,"city":31,"state":24,"zip":32,"country":33,"countryCode":24,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Ankara","06000","Turkey (Türkiye)",{"type":35,"coordinates":36},"Point",[37,38],32.85427,39.91987,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":24,"email":45},"Atakan Sezgi, M.D.","CONTACT","00905323327000","kansezgi@gmail.com",{"name":47,"role":43,"phone":48,"phoneExt":24,"email":49},"Musa Zengin, Associate Professor","00905307716235","musazengin@gmail.com",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Atakan Sezgi","Principal Investigator","100626014","flow-controlled-versus-volume-controlled-ventilation-during-balloon-dilatation-under-direct-laryngoscopy-100626014",false,"NCT07430124","Flow-Controlled Versus Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy","Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* ASA physical status I-III\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\> 65 years\n* Known or previously diagnosed pulmonary disease\n* Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ \\\u003C 50% predicted, severe restrictive or obstructive pathology)\n* Patients with markedly altered lung anatomy or function due to prior major thoracic surgery\n* Patients who were dependent on supplemental oxygen therapy in the preoperative period\n* ASA physical status IV or higher\n* Refusal or inability to provide informed consent","ALL","18 Years","65 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"NA","This prospective trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on airway pressures and oxygenation in adult patients undergoing balloon dilatation under direct laryngoscopy. Airway procedures performed under general anesthesia are associated with unique respiratory mechanics and limited ventilation conditions, making the choice of an optimal ventilation strategy particularly important.\n\nAdult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be allocated to receive either FCV or VCV during surgery. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points. The primary outcome is the PaO₂ measured 20 minutes under an FiO₂ of 0.8-1.0 after starting the ventilation under general anesthesia, reflecting early intraoperative oxygenation under stable conditions.\n\nBy providing comparative data on respiratory mechanics and oxygenation, this study aims to contribute to the identification of lung-protective ventilation strategies in patients undergoing balloon dilatation under direct laryngoscopy.",[72,73],"Airway Stenosis","Upper Airway Obstruction",[75,76,77],"Direct Laryngoscopy","Flow-Controlled Ventilation","Volume-Controlled Ventilation","2026-02-24",{"date":80,"type":81},"2026-02-25","ACTUAL",{"date":78,"type":81},{"date":84,"type":66},"2026-08-20",{"name":5,"class":6},1]