Clinical trial NCT04485741: Strados System at Center of Excellence
Official title: Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Asthma
Covid19
Lead sponsor: Strados Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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


Eligibility criteria: 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

Primary outcomes:
measure: Clinical utility as assessed by the PI
timeFrame: Periodic recording over 12 to 24 hours
Secondary outcomes:
measure: Clinical utility as assessed by other clinicians
timeFrame: Periodic recording over 12 to 24 hours
measure: Correlation of RESP data with other measures of patient status.
timeFrame: Periodic recording over 12 to 24 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
References: