Ultrasound EvaluationNCT04208438
Non-Invasive Jugular Venous Blood Volume Assessment (BVI)
An observational study of Ultrasound Evaluation, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ability of the Mespere Blood Volume Index (BVI) device to calculate the blood volume in the jugular veins by comparing the measurements from the device to volumetric measurements obtained with ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound Evaluation
- What is being tested?
- BVI Device and Point-of-Care Ultrasound
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 7 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- 18 years of age or greater
- English-speaking
- No known medical conditions requiring treatment by a physician
Who cannot join
- Substantial amount of neck hair preventing adhesion of the neck patch of the BVI
- History of congenital heart disease
- History of thoracic, neck or brain surgery
- Inability to lay supine at 30 degrees incline or 60 degrees incline for the duration of the study measurements
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Biosciences Center - Clinical Research Service Center
Detroit, Michigan, 48202
About this study
The purpose of this study is to evaluate the ability of the Mespere Blood Volume Index (BVI) device to calculate the blood volume in the jugular veins by comparing the measurements from the device to volumetric measurements obtained with ultrasound.
- Conditions
- Ultrasound Evaluation
- Being tested
- BVI Device, Point-of-Care Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVI DeviceDiagnostic test
Non-Invasive measurement of jugular blood volume using Mespere BVI device
Point-of-Care UltrasoundDiagnostic test
Point-of-Care ultrasound of external and internal jugular veins
| Study group | Role | What they receive |
|---|---|---|
| BVI Cohort | Cohort to have ultrasound and Mespere BVI device applied. Receives: Diagnostic Test: BVI Device; Diagnostic Test: Point-of-Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of jugular vein blood volume
Comparison of measurement of blood volume in jugular vein using BVI and POCUS
Measured: One Hour
Secondary outcomes (1)
Comparison of changes in measurement of jugular venous blood volume
BVI vs POCUS at head of bed angle degrees 0, 30, and 60.
Measured: One Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start5 Jun 2019
- Primary completion9 Aug 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mespere Lifesciences Inc.
- Responsible party
- Principal investigator, Mark Favot, MD, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208438
- Sponsor's protocol ID
- 20201216
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Jugular Venous Blood Volume Assessment (BVI)
- ClinicalTrials.gov ID
- NCT04208438
- Acronym / sponsor ID
- 20201216
- Conditions
- Ultrasound Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Mespere Lifesciences Inc.
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ability of the Mespere Blood Volume Index (BVI) device to calculate the blood volume in the jugular veins by comparing the measurements from the device to volumetric measurements obtained with ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BVI Cohort | – | Diagnostic Test: BVI Device, Diagnostic Test: Point-of-Care UltrasoundCohort to have ultrasound and Mespere BVI device applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- 18 years of age or greater
- English-speaking
- No known medical conditions requiring treatment by a physician
Key exclusion criteria (5 listed)
- Substantial amount of neck hair preventing adhesion of the neck patch of the BVI
- History of congenital heart disease
- History of thoracic, neck or brain surgery
- Inability to lay supine at 30 degrees incline or 60 degrees incline for the duration of the study measurements
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVI DeviceNon-Invasive measurement of jugular blood volume using Mespere BVI device | Diagnostic test | BVI Cohort |
| Point-of-Care UltrasoundPoint-of-Care ultrasound of external and internal jugular veins | Diagnostic test | BVI Cohort |
Primary outcome
Comparison of jugular vein blood volume
Time frame: One Hour
Comparison of measurement of blood volume in jugular vein using BVI and POCUS
1 secondary outcome
Comparison of changes in measurement of jugular venous blood volume
Time frame: One Hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Ultrasound Evaluation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingObservational study
Evaluation of Large Language Models in Parasternal Block Ultrasound Interpretation
Parasternal Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Evaluation, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of jugular vein blood volume (time frame: One Hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.