Strados System at Center of Excellence

Completed

• Conditions: Copd; Asthma; Covid19

• Registration Number: NCT04485741
• 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 System 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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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 clinical utility of the Strados System in enabling periodic recording and reviewing of breath sounds in patients with chronic respiratory diseases, either in the ICU, or in less continuously monitored settings, including after inpatient discharge.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Study Start: 2020-09-23
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Potential study participants will be recruited from within the Einstein Center of Excellence. Individuals who meet all of the following criteria are eligible for enrollment as study participants:

1. Males and females between the ages of 18-80:

   With documented physician-diagnosed COPD (chronic bronchitis dominant) or severe asthma, as defined either by the American Thoracic Society or the World Health Organization who are admitted for exacerbation, including those with active or suspected SARS-COV-2 infection

   OR

   Who are admitted with respiratory distress symptoms associated with SARS-COV-2 infection

2. Able to provide informed consent

3. Able to follow study procedures

4. Clinician assessment of the patient's current SARS-COV-2 status: negative or unlikely to be infected, RTPCR positive, or untested by clinically suspected

5. Accessible by telephone upon discharge

Exclusion Criteria

Subjects who meet ANY of the following criteria are not eligible for enrollment:

1. Inability or unwillingness of the participant to give written informed consent
2. History of adverse reaction or allergy to Tegaderm
3. Unwillingness or inability to comply with study procedures
4. Scheduled for thoracic procedure
5. Inaccessible by telephone post-discharge

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical utility as assessed by the PI	Periodic recording over 12 to 24 hours	To assess the clinical utility of Strados Systems in enabling periodic recording and reviewing of lung breath sounds of inpatients with chronic respiratory diseases in ICU , and less continuously monitored settings.

Secondary Outcome Measures

Name	Time	Method
Correlation of RESP data with other measures of patient status.	Periodic recording over 12 to 24 hours
Clinical utility as assessed by other clinicians	Periodic recording over 12 to 24 hours

Trial Locations

Locations (1)

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