Non-Invasive Jugular Venous Blood Volume Assessment (BVI) | NCT04208438

Studies
Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

NCT04208438

Sponsor

Wayne State University

Status

Completed

Last Update Posted

Dec 23, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Ultrasound Evaluation

Interventions

BVI Device
Point-of-Care Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 5, 2019Actual

Primary Completion Date

Aug 9, 2019Actual

Completion Date

Oct 7, 2019Actual

First Submitted Date

Dec 18, 2019

First Submission Date that Met QC Criteria

Dec 18, 2019

First Posted Date

Dec 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2019

Last Update Posted Date

Dec 23, 2019Actual

Name	Class
Mespere Lifesciences Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BVI Cohort		Cohort to have ultrasound and Mespere BVI device applied.	Diagnostic Test: BVI Device Diagnostic Test: Point-of-Care Ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BVI Device	Diagnostic Test	Non-Invasive measurement of jugular blood volume using Mespere BVI device	BVI Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of jugular vein blood volume	Comparison of measurement of blood volume in jugular vein using BVI and POCUS	One Hour

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrative Biosciences Center - Clinical Research Service Center		Detroit	Michigan	48202	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided