Non-Invasive Jugular Venous Blood Volume Assessment (BVI)
1 other identifier
observational
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2019
CompletedFirst Submitted
Initial submission to the registry
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedDecember 23, 2019
December 1, 2019
2 months
December 18, 2019
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.
Interventions
Non-Invasive measurement of jugular blood volume using Mespere BVI device
Point-of-Care ultrasound of external and internal jugular veins
Eligibility Criteria
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
- Wayne State Universitylead
- Mespere Lifesciences Inc.collaborator
Study Sites (1)
Integrative Biosciences Center - Clinical Research Service Center
Detroit, Michigan, 48202, United States
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