Non-invasive Central Venous Pressure Estimation in Pediatric Patients

Compremium AG100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Central Venous Pressure

Interventions

CPMX2DEVICE

CPMX2 - Non-invasive pressure estimation

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's National Hospital

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

RECRUITING

Outcomes

Primary Outcomes

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

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.

Time frame: Up to 4 days

Central Contacts

Damon Judges

CONTACT

+41775071995 d.judges@compremium.ch

Data from ClinicalTrials.gov

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