← Back to searchRecruitingRecruiting
Non-invasive Central Venous Pressure Estimation in Pediatric Patients
NCT06885073 · Compremium AG
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2025-03-10
Estimated completion: 2026-03-31
Last updated: 2025-09-18
Interventions
Device: CPMX2
Primary outcomes
- • Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients. (Up to 4 days)
Sponsor
Compremium AG · industry
Contacts & investigators
ContactDamon Judges · contact · d.judges@compremium.ch · +41775071995
All locations (1)
Children's National HospitalRecruiting
Washington D.C., District of Columbia, United States