Non-invasive Central Venous Pressure Estimation in Pediatric Patients
Recruiting · NCT06885073 · Interventional (participants receive a specific treatment) · Lead sponsor: Compremium AG
View the official record on ClinicalTrials.gov →Interventions studied
CPMX2
What this trial is about
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.
Who can take part
Age range
Up to 21 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Children's National Hospital - Washington D.C., District of Columbia, United States