Non-invasive Central Venous Pressure Estimation in Pediatric Patients

NCT06885073 | Recruiting FDA Device

• 1 other identifier: CPMX-CVP-Ped
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Venous Pressure

Keywords

central venous pressure; venous hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 days

Other Outcomes (1)

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

  Up to 4 days

Study Arms (1)

CPMX2 measurement arm

EXPERIMENTAL

CPMX2 measurements will be compared against invasive CVP measurements

Device: CPMX2

Interventions

CPMX2 DEVICE

CPMX2 - Non-invasive pressure estimation

CPMX2 measurement arm

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Compremium AG: lead

Study Sites (1)

Children's National Hospital

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

RECRUITING

Related Publications (1)

• Thalhammer C, Aschwanden M, Jaeger KA. Letter by Thalhammer et al regarding article, "External carotid artery-internal jugular vein fistula: a complication of internal jugular cannulation". Circulation. 2006 Sep 26;114(13):e517; author reply e518. doi: 10.1161/CIRCULATIONAHA.106.636571. No abstract available.

  PMID: 17000916 BACKGROUND

Central Study Contacts

Damon Judges

CONTACT

+41775071995; d.judges@compremium.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The investigator performing the measurement with CPMX2 is blinded to the invasive CVP measurement until the assessment is complete.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 20, 2025
• Study Start: March 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)