Clinical Research Directory

Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery

Sponsor: Spectrocor

Summary

The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric patients during open-heart surgery. Patients of less than 18 years old who, and who's guardian(s), when applicable, have signed the informed consent, can participate in the study. The primary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor can detect myocardial oxygen availability in pediatric open-heart surgery patients. The detected tissue oxygenation timely correlates with procedures affecting myocardial perfusion and other clinical parameters during the operation. Secondary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory, the SpectroCor Sensor, are safe to use, and their usability is acceptable. No comparison group is included in the study. The devices are used by the study investigators during an open-heart surgery to collect myocardial tissue spectrometer data from the pediatric population to validate and potentially further develop the monitor and it's accessory, the sterile sensor. The follow-up period for each participants ends with the discharge from the hospital. No data (such as questionnaires) are obtained directly from the study participants.

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