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Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208438
Recruitment Status : Completed
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Collaborator:
Mespere Lifesciences Inc.
Information provided by (Responsible Party):
Mark Favot, MD, Wayne State University

Brief 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.

Condition or disease Intervention/treatment
Ultrasound Evaluation Diagnostic Test: BVI Device Diagnostic Test: Point-of-Care Ultrasound

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Jugular Venous Blood Volume Assessment (BVI)
Actual Study Start Date : June 5, 2019
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
BVI Cohort
Cohort to have ultrasound and Mespere BVI device applied.
Diagnostic Test: BVI Device
Non-Invasive measurement of jugular blood volume using Mespere BVI device

Diagnostic Test: Point-of-Care Ultrasound
Point-of-Care ultrasound of external and internal jugular veins




Primary Outcome Measures :
  1. Comparison of jugular vein blood volume [ Time Frame: One Hour ]
    Comparison of measurement of blood volume in jugular vein using BVI and POCUS


Secondary Outcome Measures :
  1. Comparison of changes in measurement of jugular venous blood volume [ Time Frame: One Hour ]
    BVI vs POCUS at head of bed angle degrees 0, 30, and 60.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers
Criteria

Inclusion Criteria:

  1. 18 years of age or greater
  2. English-speaking
  3. No known medical conditions requiring treatment by a physician

Exclusion Criteria:

  1. Substantial amount of neck hair preventing adhesion of the neck patch of the BVI
  2. History of congenital heart disease
  3. History of thoracic, neck or brain surgery
  4. Inability to lay supine at 30 degrees incline or 60 degrees incline for the duration of the study measurements
  5. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208438


Locations
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United States, Michigan
Integrative Biosciences Center - Clinical Research Service Center
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Mespere Lifesciences Inc.
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Responsible Party: Mark Favot, MD, Associate Professor of Emergency Medicine, Wayne State University
ClinicalTrials.gov Identifier: NCT04208438    
Other Study ID Numbers: 20201216
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No