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RECRUITING Not applicable ClinicalTrials.gov

Non-invasive Venous Pressure Estimation

Sponsor: Yale University • ClinicalTrials.gov ID: NCT07226479

Registry updated: 2026-08-28
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Description

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.

Interventions

  • CPMX2 (Device)
    Non-invasive venous occlusion pressure monitoring 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

Conditions

Cardiac Intensive Care

Locations

  • Yale New Haven Hospital CICU — New Haven, Connecticut, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record