Non-invasive Central Venous Pressure Estimation in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Central Venous Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

The investigator performing the measurement with CPMX2 is blinded to the invasive CVP measurement until the assessment is complete.

Study Groups

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CPMX2 measurement arm

CPMX2 measurements will be compared against invasive CVP measurements

Group Type EXPERIMENTAL

CPMX2

Intervention Type DEVICE

CPMX2 - Non-invasive pressure estimation

Interventions

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CPMX2

CPMX2 - Non-invasive pressure estimation

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No