Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
ECS
1 other identifier
observational
40
1 country
1
Brief Summary
The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients The main questions it aims to answer are:
- The Devices can record myocardial spectrometric data for analysis, and
- How these measures correlate with the occurring events, procedures, and clinical parameters during the operation.
- Number of participants with device-related adverse events as assessed by CTCAE v4.0
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2023
CompletedStudy Start
First participant enrolled
October 6, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedOctober 25, 2023
October 1, 2023
2.2 years
October 5, 2023
October 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Myocardial spectrometric recording
Can the device record myocardial spectrometric data during open-heart surgery
During operation
Measurement correlation
How the measurements correlate with the occurring events, procedures, and clinical parameters during the operation.
During operation
Secondary Outcomes (1)
Adverse event assessment
From admission to discharge, up to 2 weeks
Interventions
Myocardial spectrometric measurement during open-heart Surgery
Eligibility Criteria
Patients scheduled for open-heart operation
You may qualify if:
- Any 18 to 90-year-old patient scheduled for an open-heart operation
- The ability to understand the study's objective and the risks involved.
- Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.
You may not qualify if:
- Inability to obtain an informed consent form
- Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spectrocorlead
Study Sites (1)
Heart and Lung Center
Helsinki, Uusimaa, 00029, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Raivio, PhD
Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
October 16, 2023
Study Start
October 6, 2023
Primary Completion
November 30, 2025
Study Completion
November 30, 2025
Last Updated
October 25, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share