InfectionNCT03888898
Just-in-time Elastomeric Training and Fit Testing (JET FIT)
A study testing Reusable respirator fit test and competency evaluation in people with Infection, run by Centers for Disease Control and Prevention at 3 sites in United States.
Trial summary
This is a clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Reusable respirator fit test and competency evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Apr 2019to 1 Feb 2021
- 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
- Ability to understand, the willingness to participate, and the completion of a written informed consent document
- Understands spoken and written English language as required for consent, demonstration videos, demonstration checklist, and evaluation measures
- Age > 18 years old
- Medical Evaluation Form completed by the participant and reviewed/signed by a licensed medical professional such as a registered nurse, nurse practitioner, physician assistant, or physician
- If a subject reports "yes" to any medical condition listed on the Medical Evaluation Form in Part B Questions 2, 5, 6, and/or 7, a Physician must review the subject's current and past medical history and provide documented clearance for them to participate.
- Healthcare personnel requiring respiratory protection, included in the hospital's Respiratory Protection Program and able to provide estimated number of years using respirators
Show all 10Show fewer
- Bivariate Panel facial measurements and completed data capture form
- Review of the General Photo Release Form. This allows photos and/or videos taken during study participation to be utilized in presentations and publications or the post study webinars contracted (photos/videos will not contain participant personal identifiers). Participants may decline completing this form (and if they decline, they may not be included in any photos or videos). Documented verification of agreement or decline must be addressed before registration to study
- Passed the Taste Threshold test with a score recorded of 10, 20, or 30, indicating participant can taste the sodium saccharin challenge agent for the qualitative fit test
- Eligibility Checklist
Who cannot join
- Inability to adhere to study and/or follow up procedures
- Facial hair or piercings, which may interfere with the facial seal region of the elastomeric respirator
- Individuals with facial deformities/injuries that may prevent seal and/or passing a fit test
- Known hypogeusia or ageusia (decreased ability to taste certain types of foods or the absence of taste entirely which precludes qualitative fit test)
- Inability to ensure availability for the study intervention date(s) selected by site personnel
- Chronic or current pulmonary or lung problems reported by subject (reports "yes" to any item in Part B. questions 3 or 4) on Medical Evaluation Form
- Prior problems using a respirator as reported in Part B. question 8 of the Medical Evaluation Form
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
Wayne State University
Detroit, Michigan, 48021
University of Texas
Houston, Texas, 77030
About this study
This is a clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency.
Read the detailed description
This is a national multicenter pragmatic demonstrative clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency. This study will assess participant and institution ability to rapidly convert and demonstrate proficiency using reusable respirators in the healthcare field to provide a stopgap for respiratory protection program guidelines in times of disposable respirator supply shortages. This protocol is the first in a series of three studies included in the Assessment of Elastomeric Respirators in Healthcare Delivery Settings project sponsored by the National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention (CDC). This project is funded in kind by the National Personal Protective Technology Laboratory (NPPTL), the Office of Public Health Preparedness and Response (OPHPR), and the National Center for Immunization and Respiratory Diseases (NCIRD). The first of three protocols, this will be followed by laboratory and field studies assessing disinfection methods and routine use EHMR. Three (3) United States (US) healthcare delivery organizations (University of Texas Houston, Wayne State University, and Emory University) will be included as study sites in this base protocol, individually accruing a participant sample size up to 100 HCP, with a minimum of 50 evaluable participants per site. A total sample size of 150 to 300 evaluable participants are expected to be accrued nationally. The purpose of this Base protocol is to assess feasibility of reusable EHMRs in healthcare for a just in time adaptation during respiratory infectious disease outbreaks, epidemics, pandemics, and/or disposable respirator supply shortages.
- Conditions
- Infection
- Being tested
- Reusable respirator fit test and competency evaluation, Control fit test evaluation
- Keywords
- N95 filtering facepiece respirators, elastomeric respirators, public health emergency, healthcare workers, occupational health, respiratory protection program, personal protective equipment, airborne transmissible pathogens, reusable respirator
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reusable respirator fit test and competency evaluationOther
Feasibility of rapid conversion to reusable elastomeric respirator use during public health emergency
Control fit test evaluationOther
control comparator for fit testing time threshold
| Study group | Role | What they receive |
|---|---|---|
| N95 Filtering Facepiece Respirator | Active comparator | control fit testing Receives: Other: Control fit test evaluation |
| Elastomeric Respirator | Experimental | experimental rapid conversion fit testing and competency evaluations Receives: Other: Reusable respirator fit test and competency evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit test pass and fail rates in healthcare
Participant subjective pass or fail result for sodium saccharin aerosol qualitative fit test
Measured: within 2 hours
Competency Evaluation
elastomeric half mask respirator participant "Competency Evaluation" determined by measuring competence based on tasks completed by participants using a numeric scale of 26-78 points possible. 6 competencies will be tested with subparts defined as tasks (5 competencies include 4 tasks and 1 competency includes 6 tasks). Each task is 1-3 points, with 3 points being the highest score and 1 point being the lowest possible score.
Measured: within 2 hours
Secondary outcomes (3)
User seal check predictive value
subjective pass or fail reported scores by subjects during user seal checks
Measured: within 2 hours
Bivariate Panel facial measurement accuracy for respirator size allocations
Bivariate Panel cell category allocation accuracy measured by pass or fail of fit test
Measured: within 60 days
Respirator fit test time threshold
Measurement of maximum time threshold for training required to convert subjects to disposable and reusable respirators
Measured: within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start2 Apr 2019
- Primary completion1 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Emory University, The University of Texas Health Science Center, Houston, Wayne State University
- Responsible party
- Sponsor
- Investigators
- Lewis Radonovich, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888898
- Sponsor's protocol ID
- Elastomeric Base Protocol
- Status last verified
- May 2023
- First submitted
- 11 Mar 2019
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just-in-time Elastomeric Training and Fit Testing (JET FIT)
- ClinicalTrials.gov ID
- NCT03888898
- Acronym / sponsor ID
- Elastomeric Base Protocol
- Conditions
- Infection
- Keywords
- N95 filtering facepiece respirators, elastomeric respirators, public health emergency, healthcare workers, occupational health, respiratory protection program, personal protective equipment, airborne transmissible pathogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Emory University, The University of Texas Health Science Center, Houston, Wayne State University
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 25 Mar 2019 (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.
This is a clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency.
Detailed description
This is a national multicenter pragmatic demonstrative clinical trial to evaluate feasibility of a just in time elastomeric half mask respirator (EHMR) fit test and competency training for healthcare personnel (HCP) during a simulated public health emergency. This study will assess participant and institution ability to rapidly convert and demonstrate proficiency using reusable respirators in the healthcare field to provide a stopgap for respiratory protection program guidelines in times of disposable respirator supply shortages. This protocol is the first in a series of three studies included in the Assessment of Elastomeric Respirators in Healthcare Delivery Settings project sponsored by the National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention (CDC). This project is funded in kind by the National Personal Protective Technology Laboratory (NPPTL), the Office of Public Health Preparedness and Response (OPHPR), and the National Center for Immunization and Respiratory Diseases (NCIRD). The first of three protocols, this will be followed by laboratory and field studies assessing disinfection methods and routine use EHMR. Three (3) United States (US) healthcare delivery organizations (University of Texas Houston, Wayne State University, and Emory University) will be included as study sites in this base protocol, individually accruing a participant sample size up to 100 HCP, with a minimum of 50 evaluable participants per site. A total sample size of 150 to 300 evaluable participants are expected to be accrued nationally. The purpose of this Base protocol is to assess feasibility of reusable EHMRs in healthcare for a just in time adaptation during respiratory infectious disease outbreaks, epidemics, pandemics, and/or disposable respirator supply shortages.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N95 Filtering Facepiece Respirator | Active comparator | Other: Control fit test evaluationcontrol fit testing |
| Elastomeric Respirator | Experimental | Other: Reusable respirator fit test and competency evaluationexperimental rapid conversion fit testing and competency evaluations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ability to understand, the willingness to participate, and the completion of a written informed consent document
- Understands spoken and written English language as required for consent, demonstration videos, demonstration checklist, and evaluation measures
- Age > 18 years old
- Medical Evaluation Form completed by the participant and reviewed/signed by a licensed medical professional such as a registered nurse, nurse practitioner, physician assistant, or physician
- If a subject reports "yes" to any medical condition listed on the Medical Evaluation Form in Part B Questions 2, 5, 6, and/or 7, a Physician must review the subject's current and past medical history and provide documented clearance for them to participate.
Key exclusion criteria (7 listed)
- Inability to adhere to study and/or follow up procedures
- Facial hair or piercings, which may interfere with the facial seal region of the elastomeric respirator
- Individuals with facial deformities/injuries that may prevent seal and/or passing a fit test
- Known hypogeusia or ageusia (decreased ability to taste certain types of foods or the absence of taste entirely which precludes qualitative fit test)
- Inability to ensure availability for the study intervention date(s) selected by site personnel
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 |
|---|---|---|
| Reusable respirator fit test and competency evaluationFeasibility of rapid conversion to reusable elastomeric respirator use during public health emergency | Other | Elastomeric Respirator |
| Control fit test evaluationcontrol comparator for fit testing time threshold | Other | N95 Filtering Facepiece Respirator |
Primary outcome
Fit test pass and fail rates in healthcare
Time frame: within 2 hours
Participant subjective pass or fail result for sodium saccharin aerosol qualitative fit test
Competency Evaluation
Time frame: within 2 hours
elastomeric half mask respirator participant "Competency Evaluation" determined by measuring competence based on tasks completed by participants using a numeric scale of 26-78 points possible. 6 competencies will be tested with subparts defined as tasks (5 competencies include 4 tasks and 1 competency includes 6 tasks). Each task is 1-3 points, with 3 points being the highest score and 1 point being the lowest possible score.
3 secondary outcomes
User seal check predictive value
Time frame: within 2 hours
Bivariate Panel facial measurement accuracy for respirator size allocations
Time frame: within 60 days
Respirator fit test time threshold
Time frame: within 2 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 19 May 2023.
- Individual participant dataSharing planned: No
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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.
Lewis Radonovich, MD principal investigator
Centers for Disease Control and Prevention
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reusable respirator fit test and competency evaluation in people with Infection, run by Centers for Disease Control and Prevention at 3 sites 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 10 inclusion and 7 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 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Fit test pass and fail rates in healthcare (time frame: within 2 hours). The study lists 2 primary outcomes in all. 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 19 May 2023.