Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery

This is a single-center study. Thirty participants, less than 18 years old, with a 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. The study is designed as an open, non-controlled observational study where the primary goal is to assess the monitor's ability, in combination with the sensor, to monitor and observe tissue oxygenation and safety in routine clinical practice, reflecting the real-world patient population and treatment scenarios. Therefore, no control group is used.

For the purposes of 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.