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Clinical Suitability of Artificial Intelligence ProgramsNIRS for AINCT07654244

Cerebral Near-infrared Spectroscopy in Patients Undergoing Open Cardiovascular Surgery Using Artificial Intelligence Programs: A Methodological Study

An observational study of Clinical Suitability of Artificial Intelligence Programs and Near Infrared Spectroscopy, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
CHATGPT GROUP, GEMINI GROUP and COPILOT GROUP
How many people
63 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jun 2026to 10 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • past ischemic event
  • carotid arter stenosis
  • BMI >30 kg/m2
  • serious liver or kidney disease
  • ASA 4 ve more
  • anatomical abnormality at probe site
Show all 10Show fewer
  • history of mental or neurological disease,
  • history of previous intracranial aneurysm or intracranial tumor surgery
  • history of moderate or severe pulmonary disease,
  • emergency surgery

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tayfun Sugur, specialezed contact

+90 534 564 7909

drtyfnsgr@gmail.com

Turkey (Türkiye)1 site
  • Antalya Training and Researching hospital

    Antalya, Muratpaşa

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
CHATGPT GROUP, GEMINI GROUP, COPILOT GROUP, CLINICIAN GROUP
Keywords
artificial intelligence, near infrared spectroscopy (NIRS), open cardiac surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHATGPT GROUPOther

    CHATGPT responses

  • GEMINI GROUPOther

    GEMINI responses

  • COPILOT GROUPOther

    COPILOT responses

  • CLINICIAN GROUPOther

    CLINICIAN responses

Study groups in NCT07654244
Study groupRoleWhat they receive
CHATGPT GROUPNot described
Receives: Other: CHATGPT GROUP
GEMINI GROUPNot described
Receives: Other: GEMINI GROUP
COPILOT GROUPNot described
Receives: Other: COPILOT GROUP
CLINICIAN GROUPNot described
Receives: Other: CLINICIAN GROUP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Experience

    The proximity of AI programs to the clinical experience

    Measured: 12 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start10 Jun 2026 (estimated)
  3. Primary completion10 Sep 2026 (estimated)
  4. Study completion10 Dec 2026 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654244
Sponsor's protocol ID
9/4
Acronym
NIRS for AI
Status last verified
Jun 2026
First submitted
6 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ali J, Cody J, Maldonado Y, Ramakrishna H. Near-Infrared Spectroscopy (NIRS) for Cerebral and Tissue Oximetry: Analysis of Evolving Applications. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2758-2766. doi: 10.1053/j.jvca.2021.07.015. Epub 2021 Jul 10.

    PubMed 34362641

Questions about this trial

What is this clinical trial studying?

An observational study of Clinical Suitability of Artificial Intelligence Programs and Near Infrared Spectroscopy, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tayfun Sugur, specialezed (+90 534 564 7909, drtyfnsgr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Experience (time frame: 12 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07654244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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