MedDataX Logo

Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

NCT ID: NCT04208438

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-05

Study Completion Date

2019-10-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ultrasound Evaluation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BVI Cohort

Cohort to have ultrasound and Mespere BVI device applied.

BVI Device

Intervention Type DIAGNOSTIC_TEST

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

Point-of-Care Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BVI Device

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

Intervention Type DIAGNOSTIC_TEST

Point-of-Care Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mespere Lifesciences Inc.

INDUSTRY

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mark Favot, MD

Associate Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Integrative Biosciences Center - Clinical Research Service Center

Detroit, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20201216

Identifier Type: -

Identifier Source: org_study_id