Non-invasive Venous Pressure Estimation

NCT07226479 | Recruiting FDA Device

• 1 other identifier: 2000040660
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Mean Point-of-care ultrasound (POCUS)-derived pressure measurements

  Day 1

Study Arms (1)

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.

Device: CPMX2

Interventions

CPMX2 DEVICE

Non-invasive venous occlusion pressure monitoring device

Adult CICU patients- CPMX2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Compremium AG: collaborator

Study Sites (1)

Yale New Haven Hospital CICU

New Haven, Connecticut, 06520, United States

RECRUITING

Study Officials

• Elliott Miller, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elliott Miller, MD, MS

CONTACT

203-737-6390; elliott.miller@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)