Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP) (US-JVP)
Primary Purpose
Emergencies, Cardiovascular Diseases, Neurovascular Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ultrasound scan of the internal jugular veins
Sponsored by
About this trial
This is an interventional other trial for Emergencies focused on measuring Jugular Venous Pulse, Central Venous Pressure, Ultrasounds, Validation Studies, Software Validation
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
Sites / Locations
- University Hospital of FerraraRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound scan of the internal jugular veins
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917368
Brief Title
Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)
Acronym
US-JVP
Official Title
Validation of a Novel Non-invasive Technique Based on Real-time Ultrasound B-mode to Assess the Jugular Venous Pulse
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2016 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
S. Anna Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Cardiovascular Diseases, Neurovascular Disorders
Keywords
Jugular Venous Pulse, Central Venous Pressure, Ultrasounds, Validation Studies, Software Validation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound scan of the internal jugular veins
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Ultrasound scan of the internal jugular veins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Jugular venous pulse by ultrasound
Description
Internal jugular vein cross sectional area variations in cm2 over a cardiac cycle obtained from a high-resolution B-mode sonograms sequence.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Zamboni
Phone
+390532236524
Email
zambo@unife.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Zamboni, Prof
Organizational Affiliation
University Hospital of Ferrara, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Zamboni
Phone
+390532236524
12. IPD Sharing Statement
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Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP)
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