- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07654244
Cerebral Near-infrared Spectroscopy in Patients Undergoing Open Cardiovascular Surgery Using Artificial Intelligence Programs: A Methodological Study (NIRS for AI)
12. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
63
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Tayfun Sugur, specialezed
- Telefonnummer: +90 534 564 7909
- E-mail: drtyfnsgr@gmail.com
Studiesteder
-
-
Muratpaşa
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Antalya, Muratpaşa, Tyrkiet (Türkiye)
- Antalya Training and Researching hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
CHATGPT GROUP
|
CHATGPT responses
|
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CLINICIAN GROUP
|
CLINICIAN responses
|
|
GEMINI GROUP
|
GEMINI responses
|
|
COPILOT GROUP
|
COPILOT responses
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Experience
Tidsramme: 12 hour
|
The proximity of AI programs to the clinical experience
|
12 hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Tayfun Sugur, University of Health Sciences, Antalya Training and Research Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. juni 2026
Primær færdiggørelse (Anslået)
10. september 2026
Studieafslutning (Anslået)
10. december 2026
Datoer for studieregistrering
Først indsendt
6. juni 2026
Først indsendt, der opfyldte QC-kriterier
12. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 9/4
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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