Central Venous Pressure
Conditions
Keywords
central venous pressure, venous hypertension
Brief summary
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.
Interventions
DEVICECPMX2
CPMX2 - Non-invasive pressure estimation
Sponsors
Compremium AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The investigator performing the measurement with CPMX2 is blinded to the invasive CVP measurement until the assessment is complete.
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Clinically unstable, per clinical assessment by attending physician and/or surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients. | Up to 4 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Preliminary accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP | Up to 4 days | 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 |
Countries
United States
Contacts
Primary ContactDamon Judges
Outcome results
None listed