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

Study Overview
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Brief Summary
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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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Official Title
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Utility of Remote Lung Auscultation in Transitions of Care After Pulmonary Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: RESP Biosensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between the ages of 35 and 75 with documented physician-diagnosed COPD Hospitalization with a primary diagnosis of COPD with exacerbation or pneumonia. Patient able and willing to provide informed consent. Patient can follow study procedures, including instructions for self-placement and operation of device a. Patient has experience using a smartphone Accessible by telehealth/telephone upon discharge Patient is able and willing to return to study site for study follow-up visits as necessary Exclusion Criteria: Patient unable or unwilling to provide informed consent Diagnosis of COPD is uncertain Plan for discharge to location other than the patient's home (eg, Nursing Home, Rehabilitation facility) Patient with end-stage medical condition with expected survival no more than 3 months History of adverse reaction or allergy to TegaDerm® Inaccessible by telehealth/telephone post discharge

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- |
| Participants<br> | Device: RESP Biosensor<br>* The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.<br>* Other names: RESP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Univariate and multivariate assessment of predictors of 30 day respiratory-disease specific hospital readmission rate |  | Periodic recording over 24 hours for 30 days | 
| Univariate and multivariate assessment of predictors of 30 day total respiratory exacerbation rate (moderate + severe) |  | Periodic recording over 24 hours for 30 days |