Recruiting

CPMX2

Sponsor:

Compremium AG

Code:

NCT06885073

Conditions

Central Venous Pressure

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

CPMX2

Study Details

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

Study ID

NCT06885073

Start date

Mar 10, 2025

Status verified date

Sep, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: CPMX2 measurement arm

CPMX2 measurements will be compared against invasive CVP measurements

Interventions

CPMX2

CPMX2 - Non-invasive pressure estimation

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 and Locations

Central contacts

Damon Judges

+41775071995d.judges@compremium.ch

Locations

Children's National Hospital

Recruiting

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

More Information

Sponsor

Compremium AG

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • central venous pressure
  • venous hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Compremium AG on 2025-09-18.