imPulse™ Una Full-spectrum, Over Clothing E-stethoscope

Purpose

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

Conditions

  • Corona Virus Infection
  • Coronavirus

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individuals hospitalized within a Johns Hopkins-affiliated hospital - Able to understand and willingness to comply with study procedures - Cases - inpatients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment - Controls - inpatients without COVID-19 diagnosis and no pulmonary diagnosis or symptoms - Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

Exclusion Criteria

  • Assisted ventilation, including high flow nasal cannula, or ventilator support - Unable to comply with study procedures, defined at investigator's discretion - Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Case Inpatients with confirmed COVID-19 with pulmonary symptoms
  • Device: imPulse™ Una e-stethoscope
    The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.
  • Device: Philips Lumify Ultrasound System
    Point-of-care ultrasound
Matched Control Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms
  • Device: imPulse™ Una e-stethoscope
    The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.
  • Device: Philips Lumify Ultrasound System
    Point-of-care ultrasound

Recruiting Locations

More Details

NCT ID
NCT04556149
Status
Completed
Sponsor
Level 42 AI, Inc.

Detailed Description

This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the first step to establish the performance characteristics - sensitivity, specificity, positive and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care diagnosis of COVID-19. This will inform the utility and design of further larger-scale studies using the device.