Non-invasive Venous Pressure Estimation

Not yet recruiting

• Conditions: Cardiac Intensive Care

• Registration Number: NCT07226479
• Lead Sponsor: Yale University

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, observational, 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-06
• Study First Submitted QC: 2025-11-06
• Last Update Submitted: 2025-11-06
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2025-12-01
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean venous pressure to assess accuracy	Day 1	Mean CPMX2 external jugular occlusion pressure will be compared to invasive CVP measurement in mmHg
Number of adverse events to assess safety	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	Day 1	Safety measured by number of device deficiencies reported during study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yale New Haven Hospital CICU; 🇺🇸 New Haven, Connecticut, United States