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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
300
Feasibility of rapid conversion to reusable elastomeric respirator use during public health emergency
control comparator for fit testing time threshold
Emory University
Atlanta, Georgia, United States
Wayne State University
Detroit, Michigan, United States
University of Texas
Houston, Texas, United States
Fit test pass and fail rates in healthcare
Participant subjective pass or fail result for sodium saccharin aerosol qualitative fit test
Time frame: 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.
Time frame: within 2 hours
User seal check predictive value
subjective pass or fail reported scores by subjects during user seal checks
Time frame: 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
Time frame: within 60 days
Respirator fit test time threshold
Measurement of maximum time threshold for training required to convert subjects to disposable and reusable respirators
Time frame: within 2 hours
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