[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658857":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":26,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":59,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":26,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Bursa Sevket Yilmaz Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Postoperative Delirium","Postoperative delirium will be assessed once daily by an independent evaluator blinded to the intraoperative measurements and artificial intelligence predictions. CAM-ICU will be used for mechanically ventilated patients and the Turkish 3D-CAM will be used for patients on the ward. The participant-level outcome is the occurrence of at least one positive delirium assessment during the assessment period.","Postoperative days 1 through 5",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Association Between Baseline Middle Cerebral Artery Flow Velocity and Postoperative Delirium","Bilateral mean middle cerebral artery flow velocity will be measured preoperatively by transcranial Doppler in centimeters per second. The association between lower baseline flow velocity and the occurrence of postoperative delirium will be evaluated using logistic regression.","Preoperative baseline through postoperative day 5",{"measure":19,"description":20,"timeFrame":21},"Association Between Intraoperative Relative Middle Cerebral Artery Flow Velocity and Postoperative Delirium","Mean middle cerebral artery flow velocity measured at the intraoperative TCD time points will be expressed as a percentage of the participant's preoperative baseline value. Exploratory analyses will evaluate whether relative hypoperfusion or hyperperfusion is associated with postoperative delirium.","Intraoperative period through postoperative day 5",{"measure":23,"description":24,"timeFrame":25},"Predictive Performance of General-Purpose Large Language Models for Postoperative Delirium","Each of five fixed, recorded general-purpose large language model versions will generate an independent zero-shot delirium risk prediction using standardized perioperative data. Predictions will be locked before merging with the blinded reference outcome. Performance will be summarized using sensitivity, specificity, area under the receiver operating characteristic curve, and calibration; discrimination will be compared using the DeLong test.","Perioperative prediction through postoperative day 5 reference assessment",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","This is a single-center, prospective observational cohort study of 120 adults undergoing elective heart valve surgery under general anesthesia. All participants will receive the institution's standard anesthesia and analgesia protocol. No treatment will be assigned by the study.\n\nCerebral monitoring will include bispectral index (BIS), near-infrared spectroscopy (NIRS), and intermittent transcranial Doppler (TCD) measurements. TCD measurements will be obtained preoperatively at baseline (T0), at initiation of cardiopulmonary bypass (T1), during bypass (T2), during removal of the aortic cross-clamp (T3), and at separation from bypass (T4). Arterial blood gas parameters will be recorded at these time points and postoperatively, including a postoperative measurement and a measurement at 6 hours. The Standardized Mini-Mental State Examination will be administered preoperatively only to exclude participants with substantial baseline cognitive impairment; it will not be analyzed as an outcome.\n\nThe primary hypothesis is that a lower preoperative absolute mean middle cerebral artery blood flow velocity is associated with postoperative delirium. Exploratory analyses will assess whether intraoperative mean flow velocity normalized to baseline is associated with delirium in the direction of either hypoperfusion or hyperperfusion.\n\nPostoperative delirium will be assessed daily on postoperative days 1 through 5 by an independent blinded evaluator using CAM-ICU in mechanically ventilated patients or the Turkish 3D-CAM in ward patients. Blinding will be maintained by separating the perioperative data and artificial intelligence prediction team, the delirium assessment team, and the statistician who merges the locked datasets for analysis.\n\nFive general-purpose large language models will generate independent zero-shot delirium risk predictions for each participant using a standardized prompt and fixed recorded model versions. Predictions will be time-stamped and locked before the outcome data are merged. Model performance will be evaluated against the blinded reference standard using sensitivity, specificity, area under the receiver operating characteristic curve, and calibration. The primary clinical association will be analyzed using logistic regression, and model discrimination will be compared using the DeLong test.","Adults scheduled for elective heart valve surgery at University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital who meet the eligibility criteria.",[33],{"label":34,"type":26,"description":35,"interventionNames":26},"Elective Heart Valve Surgery Cohort","Adults undergoing elective heart valve surgery under general anesthesia with the institution's standard anesthesia and analgesia protocol. BIS, NIRS, transcranial Doppler, and arterial blood gas measurements are recorded before and during surgery, followed by blinded postoperative delirium assessment on postoperative days 1 through 5.",[37],{"name":38,"affiliation":39,"role":40},"Osman Sila Aydin, MD","Bursa Yuksek Ihtisas Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+90 505 966 10 14","osmansila@gmail.com",[47],{"facility":48,"status":26,"city":49,"state":49,"zip":26,"country":50,"countryCode":26,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital","Bursa","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],29.06013,40.19559,{"lat":55,"lon":54},[58],{"name":38,"role":43,"phone":44,"phoneExt":26,"email":45},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Osman Sila Aydin","Anesthesiology and Reanimation Specialist","100658857","transcranial-doppler-and-artificial-intelligence-prediction-of-postoperative-delirium-in-heart-valve-surgery-100658857",false,"NCT07858578","Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery","Prediction of Postoperative Delirium Using Transcranial Doppler in Heart Valve Surgery: A Prospective Observational Cohort Study Comparing Artificial Intelligence Models","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective heart valve surgery\n* Undergoing surgery under general anesthesia according to the study's standardized anesthesia and analgesia protocol\n* Adequate signal quality for intraoperative BIS, NIRS, and transcranial Doppler measurements\n* Written informed consent provided by the participant or legally authorized representative\n\nExclusion Criteria:\n\n* Emergency or salvage surgery\n* Redo or reoperation cardiac surgery\n* Preoperative Standardized Mini-Mental State Examination score below 24 of 30, known dementia, active delirium, or psychotic disorder\n* Stroke or transient ischemic attack within the previous 3 months\n* Postoperative prolonged intubation or requirement for extracorporeal membrane oxygenation or an intra-aortic balloon pump\n* Parkinson disease, epilepsy, multiple sclerosis, or another neurodegenerative disorder\n* Carotid stenosis detected on preoperative carotid Doppler ultrasonography","ALL","18 Years",{"count":73,"type":74},120,"ESTIMATED","OBSERVATIONAL","Postoperative delirium is a frequent complication after cardiac surgery. This prospective observational study will evaluate whether cerebral blood flow velocity measured by transcranial Doppler before and during elective heart valve surgery is associated with delirium during the first five postoperative days. Bispectral index, near-infrared spectroscopy, and arterial blood gas data will also be recorded. Delirium will be assessed daily by an independent evaluator who is blinded to the intraoperative measurements and artificial intelligence predictions, using CAM-ICU for mechanically ventilated patients or the Turkish 3D-CAM for patients on the ward.\n\nThe study will also compare zero-shot delirium risk predictions from five general-purpose large language models (Claude, GPT, Gemini, Grok, and Kimi) with the blinded clinical assessments. The models will not be trained on data from the study cohort.",[78,79],"Postoperative Delirium","Heart Valve Diseases",[81,82,83,84,85,86],"Transcranial Doppler Ultrasound","Cerebral Blood Flow Velocity","Near-Infrared Spectroscopy","Bispectral Index Monitoring","Artificial Intelligence","Large Language Models","NOT_YET_RECRUITING","2026-09-29",{"date":90,"type":91},"2026-10-05","ACTUAL",{"date":93,"type":74},"2026-10-01",{"date":95,"type":74},"2027-08-01",{"name":61,"class":6},1]