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

Launched by LEVEL 42 AI, INC. · Sep 15, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • 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