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

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Device: RESP Biosensor

• Registration Number: NCT05661435
• Lead Sponsor: Strados Labs, Inc.

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Study Start: 2023-03-15
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

   a. Patient has experience using a smartphone

5. Accessible by telehealth/telephone upon discharge

6. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	RESP Biosensor	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States