Measuring oxygen levels in the heart during open-heart surgery
Official title: Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
Run by Spectrocor · NCT06084091 · Data updated 2026-11-12
This study is testing a new device that measures oxygen levels in the heart during open-heart surgery to see how it affects recovery and heart function afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Spectrocor Industry-sponsored |
| Locations | 1 site (Helsinki, Uusimaa) |
| Status | Recruiting |
| Started | October 6, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT06084091 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 18 to 90 scheduled for open-heart surgery who can provide informed consent.
✕Probably not a fit
Patients who are unable to provide informed consent or belong to vulnerable populations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety and performance of a device that measures myocardial oxygen saturation during open-heart surgery. It will record spectrometric data to analyze how these measurements correlate with clinical events and parameters during the procedure. The study will monitor the depth of ischemia and its relationship to postoperative heart function and morbidity. A qualified monitor will oversee the trial to ensure compliance with Good Clinical Practice and quality standards.
Why it matters
Potential benefit: If successful, this study could improve intraoperative monitoring and outcomes for patients undergoing open-heart surgery.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving intraoperative monitoring techniques.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any 18 to 90-year-old patient scheduled for an open-heart operation * The ability to understand the study's objective and the risks involved. * Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation. Exclusion Criteria: * Inability to obtain an informed consent form * Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
Where it's running
-
Heart and Lung Center
Helsinki, Uusimaa, Finland Recruiting
Study contacts
- Principal investigator: Peter Raivio, PhD — Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
- Study coordinator: Peter Raivio, PhD
- Email: peter.raivio@hus.fi
- Phone: +358 50 4272283
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.