Non-invasive Central Venous Pressure Estimation in Pediatric Patients
ConditionCentral Venous Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorCompremium AG
About this trial
Central Venous Pressure (CVP) is a standard parameter for hemodynamic monitoring and is currently measured through the insertion of a catheter. The pediatric population is especially vulnerable to risks associated to this invasive procedure, including infection, thrombosis, and pneumothorax. The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device (CPMX2) in children equipped with an invasive catheter for CVP monitoring as part of standard of care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Male or female
Age: birth to 21 years of age
Equipped with a central venous catheter (CVC) for central venous pressure (CVP) monitoring indication as part of standard of care, or undergoing cardiac catheterization.
Disqualifiers
Weight less than 2.5kg at the time of enrollment.
Bilateral external jugular veins not accessible due to vascular access or dressing.
Bilateral skin lesion contraindicating neck Ultrasound
Active bleeding
Trial design
Design model
Single group
Treatments tested in this trial
CPMX2
DeviceCPMX2 - Non-invasive pressure estimation
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: CPMX2 measurement armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients.
Safety: Safety of the device shall be evaluated by systematically reporting DDs, ADEs and SADEs and by monitoring the frequency and incidence of these events. The practitioner will be asked to identify any new risks arising during the measurements using the investigational device.
Time frame
Up to 4 daysOther outcomes
1
Preliminary accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP
Preliminary accuracy: Accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP will be evaluated against concomitant invasive CVP measurement with the standard of care catheter by computing the correlation coefficient and Bland-Altman analysis
Time frame
Up to 4 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov