Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSpectrocor
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Myocardial spectrometric measurement
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov