Pediatric Cardiac Oxygenation Monitoring During Open-Heart Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center observational study, up to 30 pediatric patients under 18 undergoing elective open-heart surgery will be monitored with the SpectroCor system to observe tissue oxygenation during the procedure. The study aims to determine if the monitor’s readings align with perioperative changes in myocardial perfusion and other clinical parameters, and to assess safety and usability. No control group is included, and real-world clinical practice is used to reflect routine use. Age categories follow the pediatric framework to account for developmental differences.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Scheduled for open-heart surgery.
* Age \<18
* Signed informed consent

Exclusion Criteria:

• Inability to provide informed consent

Where it's running

• HUS New Childrens Hospital
  Helsinki, Uusimaa, Finland Recruiting

Study contacts

• Principal investigator: Henri Haapanen, PhD — Helsinki University Hospital (HUS)
• Study coordinator: Kalle Kotilahti
• Email: kalle@spectrocor.com
• Phone: +358449016550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.