Recruiting

Non-Invasive CPV

Sponsor:

Yale University

Code:

NCT07226479

Conditions

Cardiac Intensive Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CPMX2

Study Details

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.

Conditions

Cardiac Intensive Care

Study ID

NCT07226479

Start date

Jan 6, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Adult CICU patients- CPMX2

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.

Interventions

CPMX2

Non-invasive venous occlusion pressure monitoring device

Primary outcome measure

  • Mean venous pressure to assess accuracy [ Time Frame: Day 1 ]
  • Number of adverse events to assess safety [ Time Frame: Day 1 ]
  • Number of device deficiencies to assess safety [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Mark Jacobs, MD MBA MS

203-688-2176mark.jacobs@yale.edu

Locations

Yale New Haven Hospital CICU

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-08-28.