Non-invasive Venous Pressure Estimation
Purpose
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.
Condition
- Cardiac Intensive Care
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Adult patients admitted to the CICU with invasive CVP/RA pressure measurements (Central line or pulmonary artery catheter) placed by standard of care as determined by the treating team before enrollment. With-in participant design.
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
Recruiting Locations
New Haven, Connecticut 06520
More Details
- Status
- Recruiting
- Sponsor
- Yale University