Non-invasive central venous pressure estimation using an external jugular venous occlusion device
Non-invasive Central Venous Pressure Estimation in Cardiac Intensive Care
This trial tests whether a non-invasive neck device (CPMX2) can estimate central venous pressure in adult cardiac ICU patients who already have invasive CVP monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07226479 on ClinicalTrials.gov |
What this trial studies
This single-center, single-arm, investigator-blinded feasibility study will enroll adult CICU patients who already have invasive central venous pressure/right atrial monitoring. Each participant will have concurrent non-invasive external jugular venous occlusion pressure measurements taken with the CPMX2 device while standard invasive CVP readings are recorded. The study compares the non-invasive and invasive measurements within the same patients to gather preliminary data on safety, feasibility, and accuracy. Key exclusions include positive-pressure ventilation, non-visible external jugular veins, bilateral venous thrombosis, and neck skin lesions or dressings that prevent device placement.
Who should consider this trial
Good fit: Ideal candidates are adult cardiac ICU patients who already have invasive CVP/RA monitoring, have visible external jugular veins, are not on positive-pressure ventilation, and have no bilateral neck venous thrombosis or obstructing neck dressings.
Not a fit: Patients on positive-pressure ventilation, with non-visible external jugular veins, bilateral venous thrombosis, neck skin issues preventing access, or severe tricuspid regurgitation are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, this approach could provide a safe, non-invasive way to estimate central venous pressure and reduce reliance on invasive lines for some CICU monitoring needs.
How similar studies have performed: Prior non-invasive CVP approaches (eg, ultrasound jugular measures and prototype devices) have shown mixed and preliminary results, so this method remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital CICU — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Elliott Miller, MD, MHS — Yale University
- Study coordinator: Elliott Miller, MD, MS
- Email: elliott.miller@yale.edu
- Phone: 203-737-6390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.