Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

December 18, 2019 updated by: Mark Favot, MD, Wayne State University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Integrative Biosciences Center - Clinical Research Service Center

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

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

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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of jugular vein blood volume
Time Frame: One Hour
Comparison of measurement of blood volume in jugular vein using BVI and POCUS
One Hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One Hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

Mespere Lifesciences Inc.

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)

June 5, 2019

Primary Completion (Actual)

August 9, 2019

Study Completion (Actual)

October 7, 2019

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 20201216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug 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.

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