Non-invasive Central Venous Pressure Estimation in Pediatric Patients

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.

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Key information

Conditions

Central Venous Pressure

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPMX2

Device

CPMX2 - Non-invasive pressure estimation

Primary outcomes

Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients.

Time frame: 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 outcomes

Preliminary accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Damon Judges

CONTACT

[email protected]

+41775071995

Sponsors and collaborators

Lead sponsor

Compremium AG

Industry

Registry information

Acronym: CPMX-CVP-Ped

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 20, 2025
Registry last updated: Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed