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.
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.
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
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
Johns Hopkins School of Medicine
Baltimore, Maryland, United States