RecruitingNot ApplicableNCT06885073

Non-invasive Central Venous Pressure Estimation in Pediatric Patients


Sponsor

Compremium AG

Enrollment

100 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive ultrasound technique to estimate central venous pressure (a measure of how much fluid is in the body's circulation) in children and young people, comparing it against the readings from a standard catheter already placed for medical care. **You may be eligible if...** - You are between birth and 21 years old - You already have a central venous catheter (a special IV line near the heart) placed as part of your standard medical care, OR you are undergoing a cardiac catheterization procedure **You may NOT be eligible if...** - You weigh less than 2.5 kg at enrollment - Both sides of your neck are inaccessible for ultrasound due to dressings or IV lines - You have skin conditions on the neck that prevent ultrasound - You are actively bleeding - You are clinically unstable, per your doctor's assessment Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECPMX2

CPMX2 - Non-invasive pressure estimation


Locations(1)

Children's National Hospital

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

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NCT06885073


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