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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05661435
• Other study ID #: SL-RS-TJUH01
• Status: Withdrawn
• Start date: March 15, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Strados Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Strados Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Univariate and multivariate assessment of predictors of 30 day respiratory-disease specific hospital readmission rate		Periodic recording over 24 hours for 30 days
Secondary	Univariate and multivariate assessment of predictors of 30 day total respiratory exacerbation rate (moderate + severe)		Periodic recording over 24 hours for 30 days