[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626205":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":38,"locations":47,"responsibleParty":73,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Koşuyolu Kartal Heart Training and Research Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional oxygen mask (COM)","ACTIVE_COMPARATOR","Up to 15 liters\u002Fmin via oxygen mask",[13],"Device: High-Flow Nasal Oxygen Therapy (HFNOT)",{"label":15,"type":10,"description":16,"interventionNames":17},"High-flow nasal oxygen therapy (HFNOT)","Warmed, humidified up to 70 L min-¹, FiO₂ 0.21-1.00 via dedicated nasal cannula",[18],"Device: Conventional Oxygen Mask (COM)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","High-Flow Nasal Oxygen Therapy (HFNOT)","Heated and humidified oxygen will be administered through a high-flow nasal cannula. Flow rates will up to 70 L\u002Fmin with an FiO₂ of 0.21 to 1.00, delivered at a temperature of 37°C. The intervention will be applied from entry into the operating room until the end of the surgical procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional Oxygen Mask (COM)","Oxygen will be delivered via a standard face mask up to 15 L\u002Fmin with an FiO₂ of 0.21-1.00. The oxygen support will be provided from entry into the operating room until the end of the procedure during sedoanalgesia-guided non-intubated VATS pericardial window surgery.",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Atakan ERKILINC, MD, Ass. Prof.","Kosuyolu Kartal Heart Training and Research Hospital","STUDY_CHAIR",{"name":36,"affiliation":33,"role":37},"Esin ERDEM, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Ebru GIRGIN DINC, MD","CONTACT","905446948852","grgnebru@gmail.com",{"name":36,"role":41,"phone":45,"phoneExt":25,"email":46},"905333581722","esin_ner@yahoo.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":25,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Kosuyolu Heart Training and Research Hospital","RECRUITING","Istanbul","KARTAL","34860","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],28.94966,41.01384,{"lat":59,"lon":58},[62,64,66,69,71],{"name":63,"role":41,"phone":42,"phoneExt":25,"email":43},"Ebru GIRGIN DINC",{"name":65,"role":37,"phone":25,"phoneExt":25,"email":25},"Esin ERDEM, MD, Anaesthesiologist",{"name":67,"role":68,"phone":25,"phoneExt":25,"email":25},"Ebru GIRGIN DINC, MD, Anaesthesiologist","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":25,"phoneExt":25,"email":25},"Murat Ersin CARDAK, MD, Associate Professor",{"name":72,"role":68,"phone":25,"phoneExt":25,"email":25},"Atakan ERKILINC, MD, Associate Professor",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Ebru Girgin Dinc","MD","100626205","high-flow-nasal-oxygen-vs-face-mask-during-sedoanalgesia-in-non-intubated-thoracoscopic-pericardial-window-surgery-100626205",false,"NCT07432607","High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery","Optimizing Oxygen Delivery During Sedoanalgesia for Video-Assisted Thoracoscopic Pericardial Window: High-Flow Nasal Oxygen vs. Face Mask Oxygenation, A Prospective Comparative Study","HIFI-NIVATS","Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Scheduled for elective video-assisted thoracoscopic pericardial window procedure under sedoanalgesia\n* ASA Physical Status Classification I-III\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>75 years\n* ASA Physical Status ≥ IV\n* Body Mass Index (BMI) \\> 30 kg\u002Fm²\n* Need for inotropic support at enrollment\n* Preoperative hemodynamic instability\n* Symptomatic respiratory disease (e.g., pneumonia, nasal congestion, asthma attack)\n* Diagnosed neuromuscular disorder\n* Diagnosed tracheal stenosis\n* Local infection at the site of regional block application\n* Coagulopathy or bleeding diathesis\n* Pregnancy\n* Patients refusing sedoanalgesia\n* Patients refusing study participation\n* Conversion to general anesthesia or use of supraglottic airway intraoperatively","ALL","18 Years","75 Years",{"count":89,"type":90},60,"ESTIMATED","INTERVENTIONAL",[93],"NA","This is a prospective, randomized, parallel-group clinical trial designed to evaluate the effects of high-flow nasal oxygen therapy (HFNOT) versus conventional oxygen mask (COM) on perioperative hypoxia in patients undergoing video-assisted thoracoscopic (VATS) pericardial window procedures under sedoanalgesia. The pericardial window procedure, indicated for diagnostic and therapeutic drainage of pericardial effusion, is traditionally performed under general anesthesia. However, the use of non-intubated VATS with sedoanalgesia has gained popularity due to reduced morbidity, shorter recovery, and avoidance of complications associated with general anesthesia, especially in elderly and comorbid patients.\n\nDuring non-intubated VATS, the occurrence of hypoxia and hemodynamic instability may be exacerbated by procedural pneumothorax and underlying cardiac pathology. High-flow nasal oxygen therapy may provide physiological benefits in this setting by reducing airway resistance, improving alveolar ventilation, and minimizing dead space.\n\nThe primary outcome of the study is to compare the incidence of perioperative hypoxia between HFNOT and COM groups. Secondary outcomes include patient comfort, intraoperative oxygenation profiles, hemodynamic stability, and recovery parameters. The trial will be conducted at a single academic center with eligible patients randomized into two treatment arms.",[96],"Hypoxemia During Surgery",[98,99,100],"hypoxemia","High Flow Oxygen Therapy","non-ıntubated VATS","2026-05-03",{"date":103,"type":104},"2026-05-05","ACTUAL",{"date":106,"type":104},"2025-06-01",{"date":108,"type":90},"2027-02",{"name":75,"class":6},1]