Measuring oxygen levels in the heart during open-heart surgery
Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Spectrocor Industry-sponsored |
| Locations | 1 site (Helsinki, Uusimaa) |
| Trial ID | NCT06084091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 90 scheduled for open-heart surgery who can provide informed consent.
Not a fit: Patients who are unable to provide informed consent or belong to vulnerable populations may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in improving intraoperative monitoring techniques.
Eligibility criteria
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 this trial is running
Helsinki, Uusimaa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.