[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659383":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":35,"overallOfficials":23,"centralContacts":41,"locations":47,"responsibleParty":64,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":23,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":23,"studyType":79,"phases":23,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":50,"whyStopped":23,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Cerebral Regional Oxygen Saturation (rSO2) During Prone Positioning","Bilateral frontal cerebral regional oxygen saturation (rSO2) will be measured using near-infrared spectroscopy (NIRS). Measurements will be recorded at baseline in the supine position (T0), 15 minutes (T1), 30 minutes (T2), 45 minutes (T3), and 60 minutes (T4) after prone positioning, and after return to the supine position at the end of surgery (T5).","Intraoperative, from baseline before prone positioning to return to the supine position at the end of surgery.",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Change in Dynamic Lung Compliance (Cdyn) During Prone Positioning","Dynamic lung compliance (Cdyn) will be recorded from the anesthesia ventilator at predefined intraoperative time points: baseline in the supine position (T0), 15 minutes (T1), 30 minutes (T2), 45 minutes (T3), and 60 minutes (T4) after prone positioning, and after return to the supine position at the end of surgery (T5)",{"measure":18,"description":19,"timeFrame":12},"Change in Peak Airway Pressure (Ppeak) During Prone Positioning","Peak airway pressure (Ppeak) will be recorded from the anesthesia ventilator at T0, T1, T2, T3, T4, and T5 to evaluate changes associated with prone positioning.",{"measure":21,"description":22,"timeFrame":12},"Change in Plateau Pressure (Pplat) During Prone Positioning","Plateau pressure (Pplat) will be recorded from the anesthesia ventilator at T0, T1, T2, T3, T4, and T5 to evaluate changes during prone positioning.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","PROSPECTIVE","This prospective observational study will evaluate the relationship between respiratory mechanics and cerebral regional oxygen saturation in patients undergoing elective lumbar disc surgery in the prone position under general anesthesia.\n\nBilateral frontal cerebral oxygen saturation will be monitored using near-infrared spectroscopy (NIRS), and respiratory parameters including tidal volume, respiratory rate, Ppeak, Pplat, PEEP, and dynamic compliance will be recorded at predefined intraoperative time points. No intervention will be made to routine anesthesia, ventilation, medication, or surgical management for research purposes.","Adult patients aged 18-75 years undergoing elective lumbar disc herniation surgery in the prone position under general anesthesia at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.",[30],{"label":31,"type":23,"description":32,"interventionNames":33},"Patients Undergoing Prone Lumbar Disc Surgery","Adult patients undergoing elective lumbar disc herniation surgery in the prone position under general anesthesia. Respiratory mechanics and cerebral regional oxygen saturation will be recorded at predefined intraoperative time points without any research-related modification of routine clinical management.",[34],"Procedure: Prone Positioning",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":23},"PROCEDURE","Prone Positioning","Patients will be placed in the prone position as part of routine surgical care for lumbar disc surgery. The study will observe changes in respiratory mechanics and cerebral regional oxygen saturation before and after prone positioning. No positioning intervention will be assigned or modified for research purposes.",[31],[42],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Nurten Bakan Prof. Dr.","CONTACT","+90 216 606 33 00","nurtenbakan@hotmail.com",[48],{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":23,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital","RECRUITING","Istanbul","34000","Turkey (Türkiye)",{"type":55,"coordinates":56},"Point",[57,58],28.94966,41.01384,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":45,"phoneExt":23,"email":63},"Birhan Karaca, MD","birhan.karaca93@hotmail.com",{"type":65,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100659383","pulmonary-mechanics-and-cerebral-oxygenation-during-prone-lumbar-disc-surgery-100659383",false,"NCT07862257","Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery","Evaluation of the Relationship Between Changes in Pulmonary Mechanics and Ventilatory Energy Load and Cerebral Oxygenation During Lumbar Disc Surgery in the Prone Position","Inclusion Criteria:\n\n* Age 18-75 years\n* Written informed consent\n* Scheduled for elective lumbar disc herniation surgery\n* ASA physical status I-III\n* Volume-controlled ventilation\n\nExclusion Criteria:\n\n* History of increased intracranial pressure\n* Conditions preventing placement of cerebral NIRS probes\n* Development of severe intraoperative complications\n* Significant hemodynamic instability\n* Known cerebrovascular disease or severe carotid artery disease\n* Hemoglobin \\\u003C10 g\u002FdL or anticipated major bleeding\n* Severe heart failure (EF \\\u003C40%)\n* Advanced COPD or restrictive lung disease\n* Orthopedic or neurological conditions preventing tolerance of the prone position","ALL","18 Years","75 Years",{"count":77,"type":78},100,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the relationship between changes in respiratory mechanics and cerebral oxygenation in adult patients undergoing elective lumbar disc surgery in the prone position under general anesthesia.\n\nCerebral regional oxygen saturation will be monitored using bilateral frontal near-infrared spectroscopy (NIRS), while respiratory parameters including tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, and dynamic compliance will be recorded from the anesthesia ventilator. Measurements will be obtained at predefined time points before and after positioning the patient prone and after returning to the supine position at the end of surgery.\n\nNo changes will be made to anesthesia, ventilation, medication doses, or surgical management for research purposes. All clinical care will be provided according to routine practice by the responsible anesthesia team. The study will investigate whether changes in respiratory mechanics during prone positioning are associated with changes in cerebral regional oxygen saturation.",[82,83,84],"Lumbar Disc Herniation","Respiratory Mechanics","Cerebral Oxygenation",[86,87,83,88,89,90],"Prone Position","Regional Cerebral Oxygen Saturation","Mechanical Power","Lumbar Disc Surgery","Mechanical Ventilation","2026-10-07",{"date":93,"type":94},"2026-10-09","ACTUAL",{"date":96,"type":94},"2026-09-09",{"date":98,"type":78},"2027-01-30",{"name":5,"class":6},1]