Strados System at Center of Excellence

Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment.

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Study Overview

• Status: Completed
• Conditions: Covid19; Asthma; Copd
• Intervention / Treatment: Device: RESP

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are admitted for exacerbation of chronic airway disease (COPD or severe asthma) or for respiratory distress symptoms associated with SARS-COV-2 infection for 1 to 3 weeks to ICU or specialty floor with access to telemedicine monitoring

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical utility as assessed by the PI	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.	Periodic recording over 12 to 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Strados Labs, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SL-RS-AEMC01

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: No