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

NCT ID: NCT05661435

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2023-12-30

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

RESP Biosensor

Intervention Type: DEVICE

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

Interventions

RESP Biosensor

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

Intervention Type: DEVICE

Other Intervention Names

RESP

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Strados Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

SL-RS-TJUH01

Identifier Type: -

Identifier Source: org_study_id