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

Cardiovascular Diseases Clinical Trial

Official title: Validation of a Novel Non-invasive Technique Based on Real-time Ultrasound B-mode to Assess the Jugular Venous Pulse

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Emergencies
• Neurovascular Disorders

• NCT number: NCT03917368
• Study type: Interventional
• Source: S. Anna Hospital
• Contact: Paolo Zamboni
• Phone: +390532236524
• Email: zambo@unife.it
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2016
• Completion date: May 31, 2020