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

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

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: RESP Biosensor

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center
    • Philadelphia, Pennsylvania, United States, 19141
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are admitted to the hospital for exacerbation of COPD

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants	Device: RESP Biosensor; The RESP Biosensor will be placed on the patient for periodic recording of auscultory sound.; Other Names: RESP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Strados Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2023
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SL-RS-TJUH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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