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Non-invasive Venous Pressure Estimation

RecruitingNAAges 18 Years - anyAllYale University
NCT07226479 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • CPMX2
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Where

1 site
Yale New Haven Hospital CICU
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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