Non-invasive central venous pressure monitoring in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study will compare non-invasive venous occlusion pressure (VOP) readings from the CPMX2 ultrasound device with invasive central venous pressure (CVP) measurements in pediatric patients who already have a central venous catheter as part of standard care. The study will enroll patients from birth to 21 years old, with exclusions for very low weight, inaccessible neck veins, skin lesions, active bleeding, or clinical instability. Safety endpoints will document any device-related adverse events and feasibility endpoints will compare agreement between CPMX2 and invasive CVP values. The study is conducted at a single center (Children's National Hospital) and is intended to generate preliminary safety and performance data.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Damon Judges
• Email: d.judges@compremium.ch
• Phone: +41775071995

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.