Yale New Haven Hospital CICU
New Haven, Connecticut, 06520, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07226479
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 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
CPMX2
DeviceNon-invasive venous occlusion pressure monitoring device
Primary outcomes
-
Mean venous pressure to assess accuracy
Time frame: Day 1
Mean CPMX2 external jugular occlusion pressure will be compared to invasive CVP measurement in mmHg
-
Number of adverse events to assess safety
Time frame: 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
Time frame: Day 1
Safety measured by number of device deficiencies reported during study
Secondary outcomes
-
Mean Point-of-care ultrasound (POCUS)-derived pressure measurements
Time frame: Day 1
Mean POCUS-derived pressure measurements as defined by current clinical guidelines (calculated using inferior vena cava (IVC) collapsibility and diameter measurements)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Yale University
Other
Collaborators
- Compremium AG
Registry information
Official study title
Non-invasive Central Venous Pressure Estimation in Cardiac Intensive Care
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 10, 2025
- Registry last updated
- Jan 21, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.