Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)

Last updated: April 16, 2019
Sponsor: S. Anna Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT03917368
RF-2013-02358029
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The jugular venous pulse (JVP) reflects changes in the right atrial pressure and its evaluation can be useful in managing many emergency conditions for guiding the fluid administration as well as in the diagnosis and/or prognosis of many heart and lung diseases. The present study aims: i) To validate a novel ultrasonographic (US) technique for obtaining the JVP from a high-resolution B-mode sonograms sequence, recording the changes of the cross-sectional area (CSA) of the internal jugular veins (IJV) over the cardiac cycle; ii) To develop physical and mathematical models capable of providing an indirect estimate of central venous pressure (CVP) from the changes in IJV-CSA acquired through the US investigation, and iii) To test the transferability of the novel US-JVP technique in a clinical setting.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Adult (age ≥18 years) hospitalized patients, spontaneous breathing, requiring ascheduled central venous catheterization and measurement of the central venouspressure as part of their usual care;

  • Capacity to give informed consent.

Exclusion

Exclusion criteria:

  • Central venous catheterization via the internal jugular venous access

Study Design

Total Participants: 300
Study Start date:
September 16, 2016
Estimated Completion Date:
May 31, 2020

Study Description

The study will be articulated in different phases, encompassing data collection, development of physical and mathematical models, statistical evaluations, and software implementation. The clinical experimental phase of the study (data collection) will involve hospitalized adult patients requiring a scheduled central venous catheterization and measurement of the CVP as part of their usual care. The latter will be used as the gold standard measure of CVP for the subsequent data processing and analysis. A small sample of healthy adult volunteers will also be recruited only for the non-invasive US evaluation of the JVP. The validation processes will include assessment of the diagnostic power of the US-JVP estimated CVP values and US-JVP waveforms, including evaluation of sensibility, specificity, predictive positive and negative values, accuracy and precision.

Connect with a study center

  • University Hospital of Ferrara

    Ferrara, 44124
    Italy

    Active - Recruiting

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