Strados System at Center of Excellence

  • STATUS
    Recruiting
  • End date
    Aug 31, 2021
  • participants needed
    30
  • sponsor
    Strados Labs, Inc.
Updated on 21 February 2021

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Details
Condition Chronic Obstructive Lung Disease, Asthma, Allergies & Asthma, COPD (Chronic Obstructive Pulmonary Disease), Asthma (Pediatric), Reactive Airway Disease, COVID19, chronic obstructive pulmonary disease, asthmatic, bronchial asthma, COPD, chronic obstructive pulmonary disease (copd)
Treatment RESP, RESP
Clinical Study IdentifierNCT04485741
SponsorStrados Labs, Inc.
Last Modified on21 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Allergies & Asthma or bronchial asthma or COPD or COPD (Chronic Obstructive Pulmonary Disease) or Asthma or Reactive Airway Disease or chronic obstruc...?
Do you have any of these conditions: chronic obstructive pulmonary disease or asthmatic or chronic obstructive pulmonary disease (copd) or Allergies & Asthma or Asthma or bronchial asthma...?
Do you have any of these conditions: Chronic Obstructive Lung Disease or Allergies & Asthma or COPD or chronic obstructive pulmonary disease (copd) or Asthma or asthmatic or bronchial ast...?
Do you have any of these conditions: COPD or Asthma (Pediatric) or COVID19 or bronchial asthma or chronic obstructive pulmonary disease or Chronic Obstructive Lung Disease or asthmatic or...?
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
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
\. Able to provide informed consent
\. Able to follow study procedures
\. Clinician assessment of the patient's current SARS-COV-2 status: negative
or unlikely to be infected, RTPCR positive, or untested by clinically
suspected
\. Accessible by telephone upon discharge

Exclusion Criteria

Subjects who meet ANY of the following criteria are not eligible for
enrollment
Inability or unwillingness of the participant to give written informed consent
History of adverse reaction or allergy to Tegaderm
Unwillingness or inability to comply with study procedures
Scheduled for thoracic procedure
Inaccessible by telephone post-discharge
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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