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Non-invasive Venous Pressure Estimation

NCT ID: NCT07226479

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Cardiac Intensive Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CPMX2

Intervention Type DEVICE

Non-invasive venous occlusion pressure monitoring device

Interventions

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CPMX2

Non-invasive venous occlusion pressure monitoring device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Compremium AG

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elliott Miller, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital CICU

New Haven, Connecticut, United States

Site Status

Countries

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United States

Central Contacts

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Elliott Miller, MD, MS

Role: CONTACT

Phone: 203-737-6390

Email: [email protected]

Other Identifiers

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2000040660

Identifier Type: -

Identifier Source: org_study_id