NCT06885073NARecruiting
Non-invasive Central Venous Pressure Estimation in Pediatric Patients
Compremium AG
Start Date
3/10/2025
Completion Date
3/31/2026
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.
Eligibility Criteria
Age Range: No minimum to 21 years
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
Interventions
DEVICE
CPMX2
Conditions
Central Venous Pressure
Locations
Children's National Hospital
Washington D.C., District of Columbia 20010
United States