imPulse™ Una Full-spectrum, Over Clothing E-stethoscope
NCT ID: NCT04556149
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2020-10-01
2020-12-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
Inpatients with confirmed COVID-19 with pulmonary symptoms
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.
Philips Lumify Ultrasound System
Point-of-care ultrasound
Matched Control
Inpatients without COVID-19 with non-pulmonary diagnoses or symptoms
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.
Philips Lumify Ultrasound System
Point-of-care ultrasound
Interventions
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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.
Philips Lumify Ultrasound System
Point-of-care ultrasound
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Schmidt Futures
UNKNOWN
Johns Hopkins University
OTHER
Level 42 AI, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kelly Dooley, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Ed Fuchs, MBA
Role: STUDY_DIRECTOR
Johns Hopkins School of Medicine
Locations
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Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Countries
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References
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Dooley KE, Morimoto M, Kaszuba P, Krasne M, Liu G, Fuchs E, Rexelius P, Swan J, Krawiec K, Hammond K, Ray SC, Hafen R, Schuh A, Jumbe NLS. Evidence Generation for a Host-Response Biosignature of Respiratory Disease. Viruses. 2025 Jul 2;17(7):943. doi: 10.3390/v17070943.
Other Identifiers
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00110011
Identifier Type: -
Identifier Source: org_study_id