Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Compremium AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult CICU patients- CPMX2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPMX2 | Device | Non-invasive venous occlusion pressure monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean venous pressure to assess accuracy | Mean CPMX2 external jugular occlusion pressure will be compared to invasive CVP measurement in mmHg | Day 1 |
| Number of adverse events to assess safety | Safety measured by number of adverse events related to or potentially related to the study device and device deficiencies reported during study | Day 1 |
| Number of device deficiencies to assess safety | Safety measured by number of device deficiencies reported during study | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Point-of-care ultrasound (POCUS)-derived pressure measurements | Mean POCUS-derived pressure measurements as defined by current clinical guidelines (calculated using inferior vena cava (IVC) collapsibility and diameter measurements) | Day 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elliott Miller, MD, MS | Contact | 203-737-6390 | elliott.miller@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elliott Miller, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital CICU | Recruiting | New Haven | Connecticut | 06520 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided