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Non-invasive Central Venous Pressure Estimation in Pediatric Patients

Recruiting

Who can join

Up to age 21 · All sexes

Full 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

About the 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.

What is being tested

Sponsor: Compremium AG · Participants: 100 · Started: Mar 10, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06885073

Locations in the U.S.

District of ColumbiaChildren's National Hospital, Washington D.C.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.