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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SARS-CoV-2/COVID-19 Study of the Audible and Inaudible Vibroacoustic E-stethoscope - imPulse™ Una

Conditions
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Corona Virus Infection, Coronavirus

Intervention / Treatment
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* Device: imPulse™ Una e-stethoscope
* Device: Philips Lumify Ultrasound System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Inpatients with confirmed COVID-19 with pulmonary symptoms | Device: imPulse™ Una e-stethoscope<br>* 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.<br>Device: Philips Lumify Ultrasound System<br>* Point-of-care ultrasound<br>|
| Matched Control<br>Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms | Device: imPulse™ Una e-stethoscope<br>* 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.<br>Device: Philips Lumify Ultrasound System<br>* Point-of-care ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance characteristics | Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19. | through study completion, an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infrasound, e-stethoscope, biosignature, SARS-CoV-2/COVID-19