Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

Completed

• Conditions: Ultrasound Evaluation
• Interventions: Diagnostic Test: BVI Device; Diagnostic Test: Point-of-Care Ultrasound

• Registration Number: NCT04208438
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-05
• Primary Completion: 2019-08-09
• Study Completion: 2019-10-07
• Status Verified: 2019-12
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Last Update Submitted: 2019-12-18
• Study First Posted: 2019-12-23
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BVI Cohort	BVI Device	Cohort to have ultrasound and Mespere BVI device applied.
BVI Cohort	Point-of-Care Ultrasound	Cohort to have ultrasound and Mespere BVI device applied.

Primary Outcome Measures

Name	Time	Method
Comparison of jugular vein blood volume	One Hour	Comparison of measurement of blood volume in jugular vein using BVI and POCUS

Secondary Outcome Measures

Name	Time	Method
Comparison of changes in measurement of jugular venous blood volume	One Hour	BVI vs POCUS at head of bed angle degrees 0, 30, and 60.

Trial Locations

Locations (1)

Integrative Biosciences Center - Clinical Research Service Center; 🇺🇸 Detroit, Michigan, United States