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Starting soon Observational

Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery

NCT07858578 · tracked via the Priya Life Science Turkey tracker
Sponsor
Osman Sila Aydin
Phase
Observational
Started
2026-10-01
Last updated
2026-10-05

Condition(s) studied

Postoperative DeliriumHeart Valve Diseases

Study summary

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.

The 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older * Scheduled for elective heart valve surgery * Undergoing surgery under general anesthesia according to the study's standardized anesthesia and analgesia protocol * Adequate signal quality for intraoperative BIS, NIRS, and transcranial Doppler measurements * Written informed consent provided by the participant or legally authorized representative Exclusion Criteria: * Emergency or salvage surgery * Redo or reoperation cardiac surgery * Preoperative Standardized Mini-Mental State Examination score below 24 of 30, known dementia, active delirium, or psychotic disorder * Stroke or transient ischemic attack within the previous 3 months * Postoperative prolonged intubation or requirement for extracorporeal membrane oxygenation or an intra-aortic balloon pump * Parkinson disease, epilepsy, multiple sclerosis, or another neurodegenerative disorder * Carotid stenosis detected on preoperative carotid Doppler ultrasonography

Primary outcome measure(s)

  • Incidence of Postoperative Delirium — Postoperative days 1 through 5
    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.

Trial sites (1)

FacilityCityRegionStatus
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital Bursa Bursa
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07858578 on ClinicalTrials.gov ↗ ← All trials in Turkey