Non-invasive Venous Pressure Estimation
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
| Condition(s) | Cardiac Intensive Care |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Yale University |
| Locations | New Haven, Connecticut, United States |
| Start date | 2026-01-06 |
| NCT ID | NCT07226479 |
| Official listing | https://clinicaltrials.gov/study/NCT07226479 |