Actively Recruiting
Non-invasive Venous Pressure Estimation
Led by Yale University · Updated on 2026-01-21
40
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
C
Compremium AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Non-invasive Venous Pressure Estimation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided
- Admitted to the cardiac intensive care unit with invasive CVP or right atrial pressure monitoring placed by standard care before enrollment
- No more than moderate tricuspid regurgitation as assessed by echocardiogram
You will not qualify if you...
- Receiving positive pressure ventilation (Bipap or invasive mechanical ventilation)
- External jugular veins not visible on both sides of the neck by visual or ultrasound examination
- History of thrombosis in any of these vessels bilaterally: external jugular vein, internal jugular vein, brachiocephalic vein, or superior vena cava
- Skin lesions, vascular access sites, or dressings on the neck that block access to the external jugular veins at the sternocleidomastoid muscle level
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital CICU
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
E
Elliott Miller, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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