Non-invasive Central Venous Pressure Estimation in Pediatric Patients

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Compremium AG
Study ID
NCT06885073
Status
Recruiting

Conditions

  • Central Venous Pressure

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • CPMX2 — DEVICE
    CPMX2 - Non-invasive pressure estimation

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: CPMX2 measurement arm
    CPMX2 measurements will be compared against invasive CVP measurements

Primary Outcome Measure

Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients. [ Time Frame: Up to 4 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010-

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