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

S. Anna Hospital

Status: Unknown

Conditions: Emergencies; Cardiovascular Diseases; Neurovascular Disorders

Treatments: Other: Ultrasound scan of the internal jugular veins

Study type: Interventional

Funder types: Other

Identifiers

NCT03917368

RF-2013-02358029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult (age ≥18 years) hospitalized patients, spontaneous breathing, requiring a scheduled central venous catheterization and measurement of the central venous pressure as part of their usual care;
• Capacity to give informed consent.

Exclusion criteria

• Central venous catheterization via the internal jugular venous access

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Ultrasound scan of the internal jugular veins

Experimental group

Description:

Hospitalised adult patients, requiring a scheduled central venous catheterisation and measurement of the central venous pressure as part of their usual care, will undergo a non-invasive ultrasound scan of the internal jugular veins (both side of the neck) synchronized with an ECG trace, to assess the jugular venous pulse. This procedure will be performed once throughout the study.

Treatment:

Other: Ultrasound scan of the internal jugular veins