Postoperative DeliriumNCT07858578
Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery
An observational study of Postoperative Delirium and Heart Valve Diseases, run by Osman Sila Aydin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Heart Valve Diseases
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults scheduled for elective heart valve surgery at University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital who meet the eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Bursa
Osman Sila Aydin, MD, +90 505 966 10 14, osmansila@gmail.com
About this study
Official title: Prediction of Postoperative Delirium Using Transcranial Doppler in Heart Valve Surgery: A Prospective Observational Cohort Study Comparing Artificial Intelligence Models
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.
Read the detailed description
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.
Cerebral 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.
The 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.
Postoperative 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.
Five 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.
- Conditions
- Postoperative Delirium, Heart Valve Diseases
- Keywords
- Transcranial Doppler Ultrasound, Cerebral Blood Flow Velocity, Near-Infrared Spectroscopy, Bispectral Index Monitoring, Artificial Intelligence, Large Language Models
- Medical subject headings
- Emergence Delirium, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 1 through 5
Secondary outcomes (3)
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.
Measured: Preoperative baseline through postoperative day 5
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.
Measured: Intraoperative period through postoperative day 5
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.
Measured: Perioperative prediction through postoperative day 5 reference assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osman Sila Aydin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Osman Sila Aydin, Bursa Sevket Yilmaz Training and Research Hospital
- Investigators
- Osman Sila Aydin, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858578
- Sponsor's protocol ID
- 2024-TBEK 2026/08-28
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data sharing is not planned.
Publications
Guo Y, Xu H, Wang A, Zhang M, Zhang S, Xie P. The Predictive Value of Machine Learning for Postoperative Delirium in Cardiac Surgery: Systematic Review and Meta-Analysis. J Med Internet Res. 2026 Feb 23;28:e72304. doi: 10.2196/72304.
PubMed 41730167Wahba A, Kunst G, De Somer F, Agerup Kildahl H, Milne B, Kjellberg G, Bauer A, Beyersdorf F, Berg Ravn H, Debeuckelaere G, Erdoes G, Haumann RG, Gudbjartsson T, Merkle F, Pacini D, Paternoster G, Onorati F, Ranucci M, Ristic N, Vives M, Milojevic M; EACTS/EACTAIC/EBCP Scientific Document Group. 2024 EACTS/EACTAIC/EBCP Guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2025 Feb 4;67(2):ezae354. doi: 10.1093/ejcts/ezae354. No abstract available.
PubMed 39949326Saller T, Almaghrabi M, Thudium M, Saqqa MNA, Kilger E, Juchem G. Transcranial doppler assessment of preoperative cerebral blood flow velocity in cardiac surgery patients. J Clin Monit Comput. 2026 Apr;40(2):353-361. doi: 10.1007/s10877-025-01388-7. Epub 2025 Dec 12.
PubMed 41385005Shamsi T, Janga SR, Baskaran NU, Rangasamy V, Ramachandran RV, Chen M, Ganesh S, Novack V, Subramaniam B. Temporal Trends and Severity of Postoperative Delirium in Cardiac Surgery: Insights from a Systematic Review and Meta-analysis. J Cardiothorac Vasc Anesth. 2025 Sep;39(9):2424-2435. doi: 10.1053/j.jvca.2025.05.020. Epub 2025 May 17.
PubMed 40537396