Strados System at Center of Excellence

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485741
• Other study ID #: SL-RS-AEMC01
• Status: Completed
• Start date: September 23, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Strados Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Copd
• Covid19

Intervention

Device:
• RESP
The RESP device will be placed on the patient for periodic recording of auscultory sound.

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Strados Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical utility as assessed by other clinicians		Periodic recording over 12 to 24 hours
Secondary	Correlation of RESP data with other measures of patient status.		Periodic recording over 12 to 24 hours