- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03917368
Ultrasound Evaluation of the Jugular Venous Pulse (US-JVP) (US-JVP)
April 16, 2019 updated by: Paolo Zamboni, S. Anna Hospital
Validation of a Novel Non-invasive Technique Based on Real-time Ultrasound B-mode to Assess the Jugular Venous Pulse
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ferrara, Italy, 44124
- Recruiting
- University Hospital of Ferrara
-
Contact:
- Paolo Zamboni
- Phone Number: +390532236524
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jugular venous pulse by ultrasound
Time Frame: 1 day
|
Internal jugular vein cross sectional area variations in cm2 over a cardiac cycle obtained from a high-resolution B-mode sonograms sequence.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paolo Zamboni, Prof, University Hospital of Ferrara, Italy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 16, 2016
Primary Completion (ANTICIPATED)
October 31, 2019
Study Completion (ANTICIPATED)
May 31, 2020
Study Registration Dates
First Submitted
March 19, 2019
First Submitted That Met QC Criteria
April 16, 2019
First Posted (ACTUAL)
April 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RF-2013-02358029
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinActive, not recruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on Ultrasound scan of the internal jugular veins
-
Euromedic Specialist Clinics, PolandCompletedChronic Cerebrospinal Venous InsufficiencyPoland
-
Niguarda HospitalActive, not recruitingAdvanced Heart Failure | Congestion, Venous | Systolic Chronic Heart FailureItaly
-
University of CataniaUnknownHeadache | Jugular Vein Occlusion
-
Masarykova Nemocnice v Usti nad Labem, Krajska...CompletedCentral Vein CatheterCzechia
-
Samuel Lunenfeld Research Institute, Mount Sinai...Completed
-
Mikel BatlloriInstituto de Salud Carlos IIICompletedUltrasound-guided Internal Jugular Cannulation | Central Venous Access ComplicationsSpain
-
University of CalgaryDepartment of Critical Care MedicineCompletedFluid Therapy | Cardiac Surgical ProceduresCanada
-
Chinese University of Hong KongCompletedCardiac DiseaseHong Kong
-
University Medical Center of Southern NevadaCompleted
-
University Medical Centre LjubljanaNot yet recruitingPhenylketonurias | Nutritional and Metabolic Diseases