Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorSpectrocor
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for open-heart surgery.
Age <18
Signed informed consent
Disqualifiers
None
Trial population
Pediatric patient scheduled for an open-heart operation.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Intraoperatively, from sensor insertion to removal; typically 1 to 6 hours.Secondary outcomes
1
Incidence of device or protocol-related adverse events
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.
Time frame
From informed consent through hospital discharge; assessed up to approximately 30 days2
Incidence of device or protocol-related adverse device events and serious adverse device events
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.
Time frame
From informed consent through hospital discharge; assessed up to approximately 30 days3
Incidence of device or protocol-related serious adverse events
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.
Time frame
From informed consent through hospital discharge; assessed up to approximately 30 days4
Incidence of device defeciencies
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.
Time frame
From informed consent through hospital discharge; assessed up to approximately 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Spectrocor
Lead sponsor
Hospital District of Helsinki and Uusimaa
Collaborator
Source ClinicalTrials.gov