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

NCT05661435 | Withdrawn FDA Device

• 1 other identifier: SL-RS-TJUH01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Participants

Device: RESP Biosensor

Interventions

RESP Biosensor DEVICE

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

Also known as: RESP

Participants

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are admitted to the hospital for exacerbation of COPD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Strados Labs, Inc.: lead

Study Sites (2)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: March 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

US (2)