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Recruiting NCT07226479

Non-invasive Venous Pressure Estimation

No phase Interventional Cardiac Intensive Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPMX2.
Who it may be relevant to
Registry conditions: Cardiac Intensive Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-invasive Central Venous Pressure Estimation in Cardiac Intensive Care

Overview

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.

Interventions

  • Device CPMX2
    Non-invasive venous occlusion pressure monitoring device

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Mean Point-of-care ultrasound (POCUS)-derived pressure measurements [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Yale New Haven Hospital CICU — New Haven

Identifiers

NCT: NCT07226479 · 2000040660

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗