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

NCT ID: NCT03917368

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-16
• Study Completion Date: 2020-05-31

Brief 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.

Detailed 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.

Conditions

Emergencies; Cardiovascular Diseases; Neurovascular Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ultrasound scan of the internal jugular veins

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.

Group Type: EXPERIMENTAL

Ultrasound scan of the internal jugular veins

Intervention Type: OTHER

Participants, lying at their hospital bed, will maintain their head in a fixed position on the longitudinal axis, while an operator gently places a linear probe L12-RS (7.5-11 MHz), smeared with gel, on one side of the neck, at the middle level. A 15-sec video clip of the ultrasound images will be recorded. This procedure will be repeated on the other side of the neck. In addition, three electrodes will be placed on participants' chests and connected to the ultrasound system for simultaneously measuring the ECG signal.

Interventions

Ultrasound scan of the internal jugular veins

Participants, lying at their hospital bed, will maintain their head in a fixed position on the longitudinal axis, while an operator gently places a linear probe L12-RS (7.5-11 MHz), smeared with gel, on one side of the neck, at the middle level. A 15-sec video clip of the ultrasound images will be recorded. This procedure will be repeated on the other side of the neck. In addition, three electrodes will be placed on participants' chests and connected to the ultrasound system for simultaneously measuring the ECG signal.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

S. Anna Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Zamboni

Full Professor, Director Vascular Diseases Center, University of Ferrara

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Zamboni, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Ferrara, Italy

Locations

University Hospital of Ferrara

Ferrara, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Zamboni

Role: CONTACT

zambo@unife.it

+390532236524

Facility Contacts

Paolo Zamboni

Role: primary

+390532236524

Other Identifiers

RF-2013-02358029

Identifier Type: -

Identifier Source: org_study_id