NCT04208438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

December 18, 2019

Last Update Submit

December 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of jugular vein blood volume

    Comparison of measurement of blood volume in jugular vein using BVI and POCUS

    One Hour

Secondary Outcomes (1)

  • Comparison of changes in measurement of jugular venous blood volume

    One Hour

Study Arms (1)

BVI Cohort

Cohort to have ultrasound and Mespere BVI device applied.

Diagnostic Test: BVI DeviceDiagnostic Test: Point-of-Care Ultrasound

Interventions

BVI DeviceDIAGNOSTIC_TEST

Non-Invasive measurement of jugular blood volume using Mespere BVI device

BVI Cohort

Point-of-Care ultrasound of external and internal jugular veins

BVI Cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • years of age or greater
  • English-speaking
  • No known medical conditions requiring treatment by a physician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Biosciences Center - Clinical Research Service Center

Detroit, Michigan, 48202, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 23, 2019

Study Start

June 5, 2019

Primary Completion

August 9, 2019

Study Completion

October 7, 2019

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations