RecruitingNot ApplicableNCT07226479

Non-invasive Venous Pressure Estimation

Non-invasive Central Venous Pressure Estimation in Cardiac Intensive Care

Sponsor

Yale University

Enrollment

40 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Cardiac Intensive Care

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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

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Interventions

DEVICECPMX2

Non-invasive venous occlusion pressure monitoring device

Locations(1)

Yale New Haven Hospital CICU

New Haven, Connecticut, United States

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NCT07226479