CopdNCT04485741
Strados System at Center of Excellence
An observational study of Copd and Asthma, run by Strados Labs, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- RESP
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment.
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.
- Being tested
- RESP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPDevice
Also called Strados System
The RESP device will be placed on the patient for periodic recording of auscultory sound.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periodic recording over 12 to 24 hours
Secondary outcomes (2)
Clinical utility as assessed by other clinicians
Measured: Periodic recording over 12 to 24 hours
Correlation of RESP data with other measures of patient status.
Measured: Periodic recording over 12 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start23 Sep 2020
- Primary completion28 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Strados Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485741
- Sponsor's protocol ID
- SL-RS-AEMC01
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment.
- ClinicalTrials.gov ID
- NCT04485741
- Acronym / sponsor ID
- SL-RS-AEMC01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Strados Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPAlso: Strados SystemThe RESP device will be placed on the patient for periodic recording of auscultory sound. | Device | – |
Primary outcome
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.
2 secondary outcomes
Clinical utility as assessed by other clinicians
Time frame: Periodic recording over 12 to 24 hours
Correlation of RESP data with other measures of patient status.
Time frame: Periodic recording over 12 to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Copd
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A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Copd and Asthma, run by Strados Labs, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical utility as assessed by the PI (time frame: Periodic recording over 12 to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.