[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647997":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":56,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":24,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":24,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Firat University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Flow Nasal Oxygen (HFNO)","EXPERIMENTAL","Participants receive heated humidified high-flow nasal oxygen during procedural sedation.",[13],"Device: High-Flow Nasal Oxygen (HFNO)",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Face Mask Oxygen","ACTIVE_COMPARATOR","Participants receive conventional face mask oxygen therapy during procedural sedation.",[19],"Device: Conventional Face Mask Oxygen",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE",[9],null,{"type":22,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Oxygen administered through a conventional face mask at 6 L\u002Fmin with an approximate FiO₂ of 40%.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Ahmet Aksu, Assistant Professor","CONTACT","+905303493896","drahmetaksu@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":24,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fırat University Faculty of Medicine Hospital","RECRUITING","Elâzığ","23100","Turkey (Türkiye)",{"type":42,"coordinates":43},"Point",[44,45],39.22321,38.67431,{"lat":45,"lon":44},[48,50,54],{"name":30,"role":31,"phone":32,"phoneExt":49,"email":33},"+904242333555",{"name":51,"role":31,"phone":52,"phoneExt":24,"email":53},"Ahmet Demirdağ, Assistant Professor","+905427158774","a.demirdag@firat.edu.tr",{"name":51,"role":55,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","AHMET AKSU","Assistant Professor","100647997","hfno-versus-face-mask-for-cerebral-oxygenation-during-procedural-sedation-100647997",false,"NCT07718295","HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation","Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* American Society of Anesthesiologists physical status I-IV\n* Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting\n* Ability to provide written informed consent\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Refusal or inability to provide written informed consent\n* Known neurological disorders\n* History of ischemic or hemorrhagic stroke\n* History of traumatic brain injury or previous cranial surgery\n* Peripheral arterial disease or systemic vasculitis\n* Advanced heart failure\n* Uncontrolled hypertension\n* Uncontrolled diabetes mellitus\n* Advanced chronic obstructive pulmonary disease (COPD)\n* Severe anemia (hemoglobin \\\u003C8 g\u002FdL)\n* Skin lesions or other conditions preventing proper placement of NIRS sensors\n* Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy\n* Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results","ALL","18 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"NA","This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness\u002FSedation (MOAA\u002FS) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.",[77,78,79,80],"Procedural Sedation","Hypoxemia","Cerebral Oxygenation","SEDLine",[82,83,84,85,86],"High-flow nasal oxygen (HFNO)","Procedural sedation","Cerebral oxygenation","Near-infrared spectroscopy (NIRS)","Patient State Index (PSI)","2026-07-16",{"date":89,"type":90},"2026-07-21","ACTUAL",{"date":92,"type":90},"2026-06-01",{"date":94,"type":71},"2026-12-31",{"name":5,"class":6},1]