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

Level 42 AI, Inc.34 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Corona Virus Infection Coronavirus

Interventions

imPulse™ Una e-stethoscopeDEVICE

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.

Philips Lumify Ultrasound SystemDEVICE

Point-of-care ultrasound

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Diagnostic performance characteristics

Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19.

Time frame: through study completion, an average of 2 weeks

Data from ClinicalTrials.gov

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