Non-invasive central venous pressure monitoring in children
Non-invasive Central Venous Pressure Estimation in Pediatric Patients
We will test a new non-invasive ultrasound device (CPMX2) to see if it can measure central venous pressure in children who already have a central venous catheter or are undergoing cardiac catheterization.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Compremium AG Industry-sponsored |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06885073 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children from birth to 21 years who already have a central venous catheter for CVP monitoring or are undergoing cardiac catheterization, weigh at least 2.5 kg, have accessible external jugular veins, and are clinically stable.
Not a fit: Patients unlikely to benefit include those under 2.5 kg, without a central venous catheter or inaccessible neck veins, with contraindicating neck skin lesions, active bleeding, or who are clinically unstable.
Why it matters
Potential benefit: If successful, the device could allow clinicians to measure CVP without placing a catheter, reducing risks like infection, thrombosis, and pneumothorax.
How similar studies have performed: Related non-invasive ultrasound and VOP methods have shown encouraging results in adults, but pediatric data are limited so this pediatric application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.