Strados System at Center of Excellence

NCT04485741 | Completed

• 1 other identifier: SL-RS-AEMC01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

Conditions

Copd; Asthma; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

RESP DEVICE

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

Also known as: Strados System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Strados Labs, Inc.: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: September 23, 2020
• Primary Completion: December 28, 2021
• Study Completion: December 31, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (1)