Occupational ExposureNCT04591756
Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study
A study testing Qualitative Fit Testing in people with Occupational Exposure, run by University of Virginia at 1 site in United States.
Trial summary
The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure
- What is being tested?
- Qualitative Fit Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 4 Nov 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current use of respirator within last 7 days
- Completed fit test with respirator within last 2 years
Who cannot join
- Previous adverse reaction to fit testing or testing agent
- Development of any health problem that precludes use of a respirator since last occupational health evaluation
Trial locations and contacts
1 site in 1 country.
About this study
The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing.
To this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during simulated CPR. The primary endpoint will be subject report of detection of the testing agent during a 2 minute session of simulated chest compressions on a mannequin while wearing the respiratory protection that subjects routinely wear during the course of employment.
- Conditions
- Occupational Exposure
- Being tested
- Qualitative Fit Testing
- Keywords
- Respirator, Cardiopulmonary resusitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Fit TestingOther
Qualitative fit testing with denatonium benzoate
| Study group | Role | What they receive |
|---|---|---|
| N95 Filtering Facepiece Respirator | Active comparator | Subjects will wear the model of filtering facepiece respirator that they are currently approved to wear Receives: Other: Qualitative Fit Testing |
| Elastomeric Half-Mask Respirator with P100 filters | Active comparator | Subjects will wear the model of elastomeric half mask respirator that they are currently approved to wear. Receives: Other: Qualitative Fit Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Detection of Testing Agent
Subject reported detection of testing agent
Measured: 2 minutes
Secondary outcomes (1)
Time to detection of testing agent
Time to subject reported detection of testing agent
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start26 Oct 2020
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Barros, University of Virginia
- Investigators
- Andrew Barros, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591756
- Sponsor's protocol ID
- HSR200209
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04591756
- Acronym / sponsor ID
- HSR200209
- Conditions
- Occupational Exposure
- Keywords
- Respirator, Cardiopulmonary resusitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 19 Oct 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.
The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing.
To this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during simulated CPR. The primary endpoint will be subject report of detection of the testing agent during a 2 minute session of simulated chest compressions on a mannequin while wearing the respiratory protection that subjects routinely wear during the course of employment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N95 Filtering Facepiece Respirator | Active comparator | Other: Qualitative Fit TestingSubjects will wear the model of filtering facepiece respirator that they are currently approved to wear |
| Elastomeric Half-Mask Respirator with P100 filters | Active comparator | Other: Qualitative Fit TestingSubjects will wear the model of elastomeric half mask respirator that they are currently approved to wear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current use of respirator within last 7 days
- Completed fit test with respirator within last 2 years
Key exclusion criteria (2 listed)
- Previous adverse reaction to fit testing or testing agent
- Development of any health problem that precludes use of a respirator since last occupational health evaluation
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 |
|---|---|---|
| Qualitative Fit TestingQualitative fit testing with denatonium benzoate | Other | Elastomeric Half-Mask Respirator with P100 filters, N95 Filtering Facepiece Respirator |
Primary outcome
Subject Detection of Testing Agent
Time frame: 2 minutes
Subject reported detection of testing agent
1 secondary outcome
Time to detection of testing agent
Time frame: 2 minutes
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 9 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Occupational Exposure
RecruitingObservational study
Admission and Management of Occupational or Other Exposures to Biodefense/Bioterrorism Agents or to Epidemic/Emerging Infectious Diseases
Occupational Accidents, Incubation Period, Infectious Disese
Recruiting
Effect of a Dietary Supplement Versus Placebo on Serum PFAS Levels in Male Firefighters
Environmental Exposure, PFAS Exposure
Recruiting
Consecutive Occupational Heat Exposure With and Without Overnight Cooling
Body Temperature Changes, Heat Stress
Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Not yet recruiting
Progressive Heat Exposure and Physiological Strain
Body Temperature Changes, Heat Stress
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.
Andrew Barros, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Fit Testing in people with Occupational Exposure, run by University of Virginia 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 2 inclusion and 2 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 9 Nov 2020. 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?
Subject Detection of Testing Agent (time frame: 2 minutes). 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 9 Nov 2020.