Overview
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 whose guardian(s), when applicable according to national legislation, 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. It is expected that the detected tissue oxygenation timely correlates with procedures affecting myocardial perfusion and other clinical parameters during the operation.
The 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 open-heart surgery to collect myocardial tissue spectrometer data from the pediatric population to validate and potentially further develop the monitor and its accessory, the sterile sensor. The follow-up period for each participant ends with discharge from the hospital. No data (such as questionnaires) are obtained directly from the study participants.
Description
This is a single-center study. Thirty participants, less than 18 years old, with planned elective open-heart surgery, will be recruited for this study. The primary purpose is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor peripheral tissue oxygenation perioperatively. This open, non-controlled observational study aims to assess the monitor's ability, in combination with the sensor, to monitor and observe tissue oxygenation and the safety of the device in routine clinical practice, reflecting the real-world patient population and treatment scenarios. Therefore, no control group is needed.
For this clinical investigation, pediatric age groups will be defined according to the ICH E11/EMA framework (neonates: 0-28 days; infants: 1-23 months; children: 2-11 years; adolescents: 12-17 years). Although these definitions originate from medicinal product regulation, they are widely accepted and provide a consistent basis for pediatric clinical research.
There is currently no separate international classification system specific to medical devices. However, the ICH E11/EMA framework is appropriate for device investigations because it reflects physiological differences in growth and development that are directly relevant to cardiac surgery and to the intended uses of the monitor and sensor. In particular, the greatest physiological differences compared to adults are found in neonates and infants, where cardiac size, myocardial composition, and perioperative risks differ substantially.
The study, therefore, aims to include patients across the pediatric spectrum with emphasis on neonates and infants, while allowing flexibility in recruitment numbers. Data from older children and adolescents can be reasonably bridged to adult data, given similarities in cardiac anatomy and physiology. This approach ensures that safety and usability are adequately assessed across the relevant pediatric subpopulations without imposing rigid subgroup quotas, which would be impractical in this rare and heterogeneous patient population.
Primary endpoint:
The ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability.
Secondary endpoints:
Incidence of (serious) adverse events, (serious) adverse device effects, and device deficiencies.
Eligibility
Inclusion Criteria:
- Scheduled for open-heart surgery.
- Age \<18
- Signed informed consent
Exclusion Criteria:
• Inability to provide informed consent
