Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

Ultrasound Evaluation Clinical Trial

Official title:

Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208438
• Other study ID #: 20201216
• Status: Completed
• Start date: June 5, 2019
• Est. completion date: October 7, 2019

Study information

• Verified date: December 2019
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 7, 2019
• Est. primary completion date: August 9, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ultrasound Evaluation

Intervention

Diagnostic Test:
• BVI Device
Non-Invasive measurement of jugular blood volume using Mespere BVI device
• Point-of-Care Ultrasound
Point-of-Care ultrasound of external and internal jugular veins

Locations

Country	Name	City	State
United States	Integrative Biosciences Center - Clinical Research Service Center	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	Mespere Lifesciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of jugular vein blood volume	Comparison of measurement of blood volume in jugular vein using BVI and POCUS	One Hour
Secondary	Comparison of changes in measurement of jugular venous blood volume	BVI vs POCUS at head of bed angle degrees 0, 30, and 60.	One Hour