- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07654244
Cerebral Near-infrared Spectroscopy in Patients Undergoing Open Cardiovascular Surgery Using Artificial Intelligence Programs: A Methodological Study (NIRS for AI)
12. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
63
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Tayfun Sugur, specialezed
- Telefonnummer: +90 534 564 7909
- E-post: drtyfnsgr@gmail.com
Studiesteder
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-
Muratpaşa
-
Antalya, Muratpaşa, Tyrkia (Türkiye)
- Antalya Training and Researching hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
CHATGPT GROUP
|
CHATGPT responses
|
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CLINICIAN GROUP
|
CLINICIAN responses
|
|
GEMINI GROUP
|
GEMINI responses
|
|
COPILOT GROUP
|
COPILOT responses
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Experience
Tidsramme: 12 hour
|
The proximity of AI programs to the clinical experience
|
12 hour
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Tayfun Sugur, University of Health Sciences, Antalya Training and Research Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
10. juni 2026
Primær fullføring (Antatt)
10. september 2026
Studiet fullført (Antatt)
10. desember 2026
Datoer for studieregistrering
Først innsendt
6. juni 2026
Først innsendt som oppfylte QC-kriteriene
12. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 9/4
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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