Non-invasive Venous Pressure Estimation

NCT ID: NCT07226479

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-06
• Study Completion Date: 2026-11-30

Brief Summary

The non-invasive central venous pressure estimation in adult cardiac intensive care units (CICU) patients study is a single-center, single-arm, investigator-blinded, interventional, intra-participant comparative, feasibility study. This study aims to assess the safety and preliminary accuracy of external jugular venous occlusion pressure measured non-invasively with the venous occlusion pressure monitoring device (CPMX2) in adult CICU patients. As a feasibility study, the primary goal is to gather preliminary data on the feasibility, safety, and effectiveness of the non-invasive CVP estimation method. Although single arm, the study will compare non-invasive CVP measurements with standard invasive CVP measurements taken concurrently. This intra-participant comparative approach is essential to validate the correlation and reliability of the non-invasive method.

Conditions

Cardiac Intensive Care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Adult CICU patients- CPMX2

Adult participants admitted to the CICU will have external jugular venous occlusion pressure measured twice non-invasively with the venous occlusion pressure monitoring device (CPMX2) and twice using standard of care invasive central venous pressure (CVP) measurements. All measurements will be taken concurrently. This is a with-in participant design.

Group Type: EXPERIMENTAL

CPMX2

Intervention Type: DEVICE

Non-invasive venous occlusion pressure monitoring device

Interventions

CPMX2

Non-invasive venous occlusion pressure monitoring device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated informed consent
• Admitted to the CICU with invasive CVP/RA pressure monitoring placed by standard of care as determined by the treating team before enrollment
• No more than moderate TR as assessed by echocardiogram

Exclusion Criteria

• Undergoing positive pressure ventilation (Bipap or invasive mechanical ventilation)
• Non-visible external jugular vein bilaterally (by visual examination or with traditional ultrasound examination)
• History of thrombosis in any of the following vessels bilaterally; external jugular vein, internal jugular vein, brachiocephalic vein or superior vena cava
• Skin lesions, vascular access sites or dressings covering neck and impeding access to the external jugular veins at the level of the muscle belly of the sternocleidomastoid muscle

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Compremium AG

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elliott Miller, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital CICU

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elliott Miller, MD, MS

Role: CONTACT

elliott.miller@yale.edu

203-737-6390

Other Identifiers

2000040660

Identifier Type: -

Identifier Source: org_study_id