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

NCT03917368 | Unknown

• 1 other identifier: RF-2013-02358029
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies; Cardiovascular Diseases; Neurovascular Disorders

Keywords

Jugular Venous Pulse; Central Venous Pressure; Ultrasounds; Validation Studies; Software Validation

Outcome Measures

Primary Outcomes (1)

• Jugular venous pulse by ultrasound

  Internal jugular vein cross sectional area variations in cm2 over a cardiac cycle obtained from a high-resolution B-mode sonograms sequence.

  1 day

Study Arms (1)

Ultrasound scan of the internal jugular veins

EXPERIMENTAL

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.

Other: Ultrasound scan of the internal jugular veins

Interventions

Ultrasound scan of the internal jugular veins 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.

Ultrasound scan of the internal jugular veins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Central venous catheterization via the internal jugular venous access

Sponsors & Collaborators

• S. Anna Hospital: lead

Study Sites (1)

University Hospital of Ferrara

Ferrara, 44124, Italy

RECRUITING

MeSH Terms

Conditions

Emergencies; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Zamboni, Prof

  University Hospital of Ferrara, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Zamboni

CONTACT

+390532236524; zambo@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Director Vascular Diseases Center, University of Ferrara

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 17, 2019
• Study Start: September 16, 2016
• Primary Completion: October 31, 2019
• Study Completion: May 31, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

IT (1)