Non-invasive Central Venous Pressure Estimation in Pediatric Patients (CPMX-CVP-Ped)

Compremium

Status: Enrolling

Conditions: Central Venous Pressure

Treatments: Device: CPMX2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06885073

CPMX-CVP-Ped

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

CPMX2 measurement arm

Experimental group

Description:

CPMX2 measurements will be compared against invasive CVP measurements

Treatment:

Device: CPMX2