Heart Defects, Congenital, Myocardial Ischemia, Reperfusion Injury, Myocardial
Conditions
Brief 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 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.
Detailed 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.
Interventions
None listed
Sponsors
Spectrocor
Hospital District of Helsinki and Uusimaa
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for open-heart surgery. * Age \<18 * Signed informed consent
Exclusion criteria
• Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to observe/monitor changes in myocardial oxygen availability | Intraoperatively, from sensor insertion to removal; typically 1 to 6 hours. | Proportion of monitor-sensor applications demonstrating expected myocardial oxygenation response - percentage of applications in which the device detects a decrease in Hb/Mb saturation and CcOx oxidation after aortic cross-clamping, an increase after de-clamping, and/or an increase after blood cardioplegia administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device or protocol-related adverse events | From informed consent through hospital discharge; assessed up to approximately 30 days | An Adverse Event (AE) is an untoward medical occurrence, unintended disease or injury, or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users, or other persons, in the context of a clinical investigation, whether related to the investigated device. This definition includes events that are anticipated as well as unanticipated events occurring in a clinical investigation related to the investigated device or the procedures involved. |
| Incidence of device or protocol-related adverse device events and serious adverse device events | From informed consent through hospital discharge; assessed up to approximately 30 days | An Adverse Device Effect (ADE) is any AE related to the use of an investigational medical device. This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device, and any event resulting from use error or from intentional misuse of the investigational medical device. A Serious Adverse Device Effect (SADE) is an ADE that has resulted in any of the consequences characteristic of a serious adverse event. SAEs related to procedures imposed by the clinical investigation plan but not with the use of the device shall not be considered Serious Adverse Device Effects. |
| Incidence of device or protocol-related serious adverse events | From informed consent through hospital discharge; assessed up to approximately 30 days | A Serious Adverse Event (SAE) is any AE that led to any of the following: a) death; b) serious deterioration in the health of the subject that resulted in any of the following: (i) life-threatening illness or injury; (ii) permanent impairment of a body structure or a body function; (iii) hospitalization or prolongation of patient hospitalization; (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; (v) chronic disease. |
| Incidence of device defeciencies | From informed consent through hospital discharge; assessed up to approximately 30 days | A Device Deficiency (DD) is any inadequacy in the identity, quality, durability, reliability, safety, or performance of an investigational device, including malfunction, use errors, or inadequacy in information supplied by the manufacturer. |
Contacts
CONTACTKalle Kotilahti
CONTACTTommi Pätilä, PhD
PRINCIPAL_INVESTIGATORHenri Haapanen, PhD
Helsinki University Hospital (HUS)
Outcome results
None listed