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| Name | Class |
|---|---|
| Emory University | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Wayne State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N95 Filtering Facepiece Respirator | Active Comparator | control fit testing |
|
| Elastomeric Respirator | Experimental | experimental rapid conversion fit testing and competency evaluations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reusable respirator fit test and competency evaluation | Other | Feasibility of rapid conversion to reusable elastomeric respirator use during public health emergency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fit test pass and fail rates in healthcare | Participant subjective pass or fail result for sodium saccharin aerosol qualitative fit test | 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. | within 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| User seal check predictive value | subjective pass or fail reported scores by subjects during user seal checks | within 2 hours |
| Bivariate Panel facial measurement accuracy for respirator size allocations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis Radonovich, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Wayne State University |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| Control fit test evaluation | Other | control comparator for fit testing time threshold |
|
Bivariate Panel cell category allocation accuracy measured by pass or fail of fit test
| within 60 days |
| Respirator fit test time threshold | Measurement of maximum time threshold for training required to convert subjects to disposable and reusable respirators | within 2 hours |
| Detroit |
| Michigan |
| 48021 |
| United States |
| University of Texas | Houston | Texas | 77030 | United States |