Cardiac Intensive Care
Conditions
Brief 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 to validate the correlation and reliability of the non-invasive method.
Interventions
DEVICECPMX2
Non-invasive venous occlusion pressure monitoring device
Sponsors
Yale University
Compremium AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean venous pressure to assess accuracy | Day 1 | Mean CPMX2 external jugular occlusion pressure will be compared to invasive CVP measurement in mmHg |
| Number of adverse events to assess safety | Day 1 | Safety measured by number of adverse events related to or potentially related to the study device and device deficiencies reported during study |
| Number of device deficiencies to assess safety | Day 1 | Safety measured by number of device deficiencies reported during study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Point-of-care ultrasound (POCUS)-derived pressure measurements | Day 1 | Mean POCUS-derived pressure measurements as defined by current clinical guidelines (calculated using inferior vena cava (IVC) collapsibility and diameter measurements) |
Countries
United States
Contacts
CONTACTMark Jacobs, MD MBA MS
PRINCIPAL_INVESTIGATORMark Jacobs, MD MBA MS
Yale University
Outcome results
None listed