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).
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
- Conditions the study is for
- Clinical Suitability of Artificial Intelligence Programs, Near Infrared Spectroscopy, Cardiac Surgery
- 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.
Turkey (Türkiye)1 site
Antalya Training and Researching hospital
Antalya, Muratpaşa
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.
- Conditions
- Clinical Suitability of Artificial Intelligence Programs, Near Infrared Spectroscopy, Cardiac Surgery
- 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 group | Role | What they receive |
|---|---|---|
| CHATGPT GROUP | Not described Receives: Other: CHATGPT GROUP | |
| GEMINI GROUP | Not described Receives: Other: GEMINI GROUP | |
| COPILOT GROUP | Not described Receives: Other: COPILOT GROUP | |
| CLINICIAN GROUP | Not described Receives: Other: CLINICIAN GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Suitability of Artificial Intelligence ProgramsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tayfun Sugur, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07654244
- Acronym / sponsor ID
- NIRS for AI / 9/4
- Conditions
- Clinical Suitability of Artificial Intelligence Programs, Near Infrared Spectroscopy, Cardiac Surgery
- Keywords
- artificial intelligence, near infrared spectroscopy (NIRS), open cardiac surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CHATGPT GROUP | – | Other: CHATGPT GROUP |
| GEMINI GROUP | – | Other: GEMINI GROUP |
| COPILOT GROUP | – | Other: COPILOT GROUP |
| CLINICIAN GROUP | – | Other: CLINICIAN GROUP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- open cardiac surgery
- elective open heart surgery
- aged 18-65
- ASA score I-III
- BMI <30 kg/m2
Key exclusion criteria (10 listed)
- past ischemic event
- carotid arter stenosis
- BMI >30 kg/m2
- serious liver or kidney disease
- ASA 4 ve more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHATGPT GROUPCHATGPT responses | Other | CHATGPT GROUP |
| GEMINI GROUPGEMINI responses | Other | GEMINI GROUP |
| COPILOT GROUPCOPILOT responses | Other | COPILOT GROUP |
| CLINICIAN GROUPCLINICIAN responses | Other | CLINICIAN GROUP |
Primary outcome
Clinical Experience
Time frame: 12 hour
The proximity of AI programs to the clinical experience
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 34362641Ali 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tayfun Sugur principal investigator
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
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.