Strados System at Center of Excellence

NCT04485741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2023-02-02

No results posted yet for this study

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Conditions

Interventions

DEVICE

RESP

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

Sponsors & Collaborators

  • Strados Labs, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2021-12-28
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04485741 on ClinicalTrials.gov