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NCT Number: NCT07654244

Cerebral Near-infrared Spectroscopy 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antalya Training and Researching hospital

Antalya, Muratpaşa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHATGPT GROUP

Other

CHATGPT responses

GEMINI GROUP

Other

GEMINI responses

COPILOT GROUP

Other

COPILOT responses

CLINICIAN GROUP

Other

CLINICIAN responses

Primary outcomes

  1. Clinical Experience

    Time frame: 12 hour

    The proximity of AI programs to the clinical experience

Study contacts

Contact information is provided by the study sponsor or research team.

Tayfun Sugur, specialezed

CONTACT

[email protected]

+90 534 564 7909

Sponsors and collaborators

Lead sponsor

Antalya Health Sciences University

Other

Registry information

Official study 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

Acronym: NIRS for AI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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