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Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of COPD

Sponsor
Strados Labs, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05661435
Collaborator
(none)
40
Enrollment
2
Locations
10.3
Anticipated Duration (Months)
20
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow and discharge patients from hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) remains a major problem. The Strados RESP Biosensor has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the associations between RESP Biosensor-acquired lung findings and subjective measures of respiratory symptoms as measured by validated measurement tools, and objective measure of respiratory physiology as determined by home spirometry

Condition or Disease Intervention/Treatment Phase
  • Device: RESP Biosensor

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of Chronic Obstructive Pulmonary Disease
Anticipated Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Participants

Device: RESP Biosensor
The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.
Other Names:
  • RESP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Statistically significant associations between RESP Biosensor-acquired lung findings and 1) subjective measure of respiratory symptoms measured by validated measurements tools and 2) home spirometry [Periodic recording over 24 hours for 30 days]

    Secondary Outcome Measures

    1. Univariate and multivariate assessment of predictors of 30 day respiratory-disease specific hospital readmission rate [Periodic recording over 24 hours for 30 days]

    2. Univariate and multivariate assessment of predictors of 30 day total respiratory exacerbation rate (moderate + severe) [Periodic recording over 24 hours for 30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Males and females between the ages of 35 and 75 with documented physician-diagnosed COPD

    2. Hospitalization with a primary diagnosis of COPD with exacerbation or pneumonia.

    3. Patient able and willing to provide informed consent.

    4. Patient can follow study procedures, including instructions for self-placement and operation of device

    1. Patient has experience using a smartphone

    1. Accessible by telehealth/telephone upon discharge

    2. Patient is able and willing to return to study site for study follow-up visits as necessary

    Exclusion Criteria:

    1. Patient unable or unwilling to provide informed consent

    2. Diagnosis of COPD is uncertain

    3. Plan for discharge to location other than the patient's home (eg, Nursing Home, Rehabilitation facility)

    4. Patient with end-stage medical condition with expected survival no more than 3 months

    5. History of adverse reaction or allergy to TegaDerm®

    6. Inaccessible by telehealth/telephone post discharge

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Albert Einstein Medical Center Philadelphia Pennsylvania United States 19141
    2 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19141

    Sponsors and Collaborators

    • Strados Labs, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Strados Labs, Inc.
    ClinicalTrials.gov Identifier:
    NCT05661435
    Other Study ID Numbers:
    • SL-RS-TJUH01
    First Posted:
    Dec 22, 2022
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Feb 2, 2023