Non-invasive Venous Pressure Estimation

Non-invasive Central Venous Pressure Estimation in Cardiac Intensive Care

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Intensive Care
• Intervention / Treatment: Device: CPMX2

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elliott Miller, MD, MS; Phone Number: 203-737-6390; Email: elliott.miller@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital CICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

Adult patients ≥18 years of age admitted to the CICU with invasive CVP pressure measurements (central line or pulmonary artery catheter placed by standard of care as determined by the treating team before enrollment).

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: CPMX2; Non-invasive venous occlusion pressure monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Point-of-care ultrasound (POCUS)-derived pressure measurements	Mean POCUS-derived pressure measurements as defined by current clinical guidelines (calculated using inferior vena cava (IVC) collapsibility and diameter measurements)	Day 1

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Compremium AG
• Investigators: Principal Investigator: Elliott Miller, MD, MHS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 6, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2000040660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No