Non-invasive Central Venous Pressure Estimation in Pediatric Patients

Not Applicable

Not yet recruiting

• Conditions: Central Venous Pressure

• Registration Number: NCT06885073
• Lead Sponsor: Compremium AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study Start: 2025-03-10
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients.	Up to 4 days	Safety: Safety of the device shall be evaluated by systematically reporting DDs, ADEs and SADEs and by monitoring the frequency and incidence of these events. The practitioner will be asked to identify any new risks arising during the measurements using the investigational device.