Cerebral Near-infrared Spectroscopy in Patients Undergoing Open Cardiovascular Surgery Using Artificial Intelligence Programs: A Methodological Study (NIRS for AI)

June 12, 2026 updated by: Antalya Health Sciences University

INTERPRETATION AND EVALUATION OF THE PROXIMITY TO CLINICAL EXPERIENCE OF CEREBRAL NEAR-INFRARED SPECTROSCOPY (NIRS) IN PATIENTS UNDERGOING OPEN CARDIOVASCULAR SURGERY USING ARTIFICIAL INTELLIGENCE PROGRAMS: A METHODOLOGICAL STUDY

The aim of the present study is to test the accuracy and reliability of AI tools in this regard by interpreting NIRS, which we routinely use for monitoring cerebral perfusion in cardiovascular surgery, with AI tools and comparing this interpretation with the interpretations of two clinicians.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

First described more than 40 years ago, this technology is a non-invasive monitoring method based on the fact that near infrared light can penetrate biological tissue, providing real-time and non-invasive information about tissue oxygenation and metabolism. Furthermore, in a clinical setting, NIRS can provide clinicians with potentially valuable information in patients with systemic and/or cerebral microcirculation disorders. NIRS is used to assess brain oxygenation, as well as to monitor local tissue and muscle oxygenation and tissue perfusion. Clinical applications of this technology include cerebral and cardiac monitoring, detection of global or regional low cardiac output status (LCOS), evaluation of treatment response, and prognosis determination. Open heart surgery is a complex surgery requiring a multidisciplinary approach. During this surgery, the heart is usually stopped, and its function is performed by the heart pump. During this time and throughout the entire operation, vital organs must be closely monitored, and adequate tissue oxygenation must be ensured. The human brain is one of the organs with the highest oxygen consumption. Therefore, it is extremely sensitive to hypoxic conditions. Furthermore, it has been noted that decreased brain oxygen saturation may be associated with postoperative neurological dysfunction and worse neurocognitive outcomes. Cerebral NIRS is increasingly being used in clinical settings to monitor brain oxygenation. This new and non-invasive technique can also function as a warning sign of cerebral ischemia and hypoxia. Additionally, real-time brain oxygenation monitoring with cerebral NIRS can be useful in detecting ischemic events during cerebrovascular procedures. Furthermore, NIRS-based management strategies aim to promote tissue oxygen delivery (including optimizing oxygenation and hemoglobin concentration and the intelligent use of intravenous fluids and inotropic drugs) while reducing tissue oxygen consumption (by reducing metabolic demand, including analgesics, sedation, and temperature control). This method, evaluated and administered only by anesthesiologists, allows us to routinely monitor brain oxygenation during the procedure and interpret it clinically, enabling us to intervene accordingly. With the increasing use of artificial intelligence (AI) tools today, the literature contains studies analyzing the clinical use and suitability of the most frequently used AI tools, such as Chat GPT (GPT-5.5), Google Gemini (Gemini 3.1 Pro), and Microsoft Copilot (365 Copilot Premium). However, the number of such studies in the literature is quite limited. Therefore, the aim of the present study is to test the accuracy and reliability of AI tools in this regard by interpreting NIRS, which we routinely use for monitoring cerebral perfusion in cardiovascular surgery, with AI tools and comparing this interpretation with the interpretations of two clinicians.

Study Type

Observational

Enrollment (Estimated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Muratpaşa
      • Antalya, Muratpaşa, Turkey (Türkiye)
        • Antalya Training and Researching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18-65 years with ASA scores I-III and BMI <30 kg/m2 who are scheduled for elective open heart surgery will be included.

Description

Inclusion Criteria:

  • open cardiac surgery
  • elective open heart surgery
  • aged 18-65
  • ASA score I-III
  • BMI <30 kg/m2

Exclusion Criteria:

  • past ischemic event
  • carotid arter stenosis
  • BMI >30 kg/m2
  • serious liver or kidney disease
  • ASA 4 ve more
  • anatomical abnormality at probe site
  • history of mental or neurological disease,
  • history of previous intracranial aneurysm or intracranial tumor surgery
  • history of moderate or severe pulmonary disease,
  • emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHATGPT GROUP
Other: CHATGPT GROUP
CHATGPT responses
CLINICIAN GROUP
Other: CLINICIAN GROUP
CLINICIAN responses
GEMINI GROUP
Other: GEMINI GROUP
GEMINI responses
COPILOT GROUP
Other: COPILOT GROUP
COPILOT responses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Experience
Time Frame: 12 hour
The proximity of AI programs to the clinical experience
12 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Health Sciences University

Investigators

  • Principal Investigator: Tayfun Sugur, University of Health Sciences, Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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