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OpenTrials
Completed

NCT Number: NCT04485741

Strados System at Center of Excellence

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recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring.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

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Key information

Conditions

COPD Asthma Bronchial Diseases COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Covid19 Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Disease, Chronic Obstructive RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

RESP

Device

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

Other names: Strados System

Primary outcomes

  1. Clinical utility as assessed by the PI

    Time frame: Periodic recording over 12 to 24 hours

    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.

Secondary outcomes

  1. Clinical utility as assessed by other clinicians

    Time frame: Periodic recording over 12 to 24 hours

  2. Correlation of RESP data with other measures of patient status.

    Time frame: Periodic recording over 12 to 24 hours

Sponsors and collaborators

Lead sponsor

Strados Labs, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2020
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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