Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery

NCT07785141 | Not Yet Recruiting

• 2 other identifiers: Ped PlegiaFIMEA/2025/004527
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Ischemia; Heart Defects, Congenital; Reperfusion Injury, Myocardial

Outcome Measures

Primary Outcomes (1)

• Ability to observe/monitor changes in myocardial oxygen availability

  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.

  Intraoperatively, from sensor insertion to removal; typically 1 to 6 hours.

Secondary Outcomes (4)

• Incidence of device or protocol-related adverse events

  From informed consent through hospital discharge; assessed up to approximately 30 days

• 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

• Incidence of device or protocol-related serious adverse events

  From informed consent through hospital discharge; assessed up to approximately 30 days

• Incidence of device defeciencies

  From informed consent through hospital discharge; assessed up to approximately 30 days

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patient scheduled for an open-heart operation.

You may qualify if:

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

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Spectrocor: lead
• Hospital District of Helsinki and Uusimaa: collaborator

Related Publications (18)

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MeSH Terms

Conditions

Myocardial Ischemia; Heart Defects, Congenital; Myocardial Reperfusion Injury

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiomyopathies; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henri Haapanen, PhD

  Helsinki University Hospital (HUS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kalle Kotilahti

CONTACT

+358449016550; kalle@spectrocor.com

Tommi Pätilä, PhD

CONTACT

+358440130770; tommi@spectrocor.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share