Volumetric Integral Phase-shift Spectroscopy for Noninvasive Detection of Hemispheric Bioimpedance Asymmetry in Acute Brain Pathology "VITAL"

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to assess the ability of the Fluids Monitor to detect hemispheric bioimpedance asymmetry associated with acute brain pathology in patients presenting with suspected Acute Ischemic Stroke (AIS).

Detailed Description

A prospective non-significant-risk (NSR) multi-site observational study. This study will examine up to 318 subjects undergoing evaluation for acute brain pathology who directly arrive at, or are transferred to, the participating sites.

Conditions

Interventions

  • VIPS Monitoring Diagnostic Test
    Other Names: CMS
    Intervention Desc: Bioimpedance asymmetry
    ARM 1: Kind: Experimental
    Label: VIPS monitoring group
    Description: The study population will consist of adult patients presenting for evaluation of acute brain pathology,

Trial Population

Males and females, aged 18 years or older, who are undergoing evaluation for acute ischemic stroke

Outcomes

Type Measure Time Frame Safety Issue
Primary Hemispheric bioimpedance asymmetry detection At the time of VIPS monitoring - day 0

Sponsors