Just-in-time Elastomeric Training and Fit Testing (JET FIT)

NCT03888898 | Completed DMC

• 1 other identifier: Elastomeric Base Protocol
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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.

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; reusable respirator

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• User seal check predictive value

  within 2 hours

• Bivariate Panel facial measurement accuracy for respirator size allocations

  within 60 days

• Respirator fit test time threshold

  within 2 hours

Study Arms (2)

N95 Filtering Facepiece Respirator

ACTIVE COMPARATOR

control fit testing

Other: Control fit test evaluation

Elastomeric Respirator

EXPERIMENTAL

experimental rapid conversion fit testing and competency evaluations

Other: Reusable respirator fit test and competency evaluation

Interventions

Reusable respirator fit test and competency evaluation OTHER

Feasibility of rapid conversion to reusable elastomeric respirator use during public health emergency

Elastomeric Respirator

Control fit test evaluation OTHER

control comparator for fit testing time threshold

N95 Filtering Facepiece Respirator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Emory University: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Wayne State University: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

Wayne State University

Detroit, Michigan, 48021, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

• Lewis Radonovich, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 25, 2019
• Study Start: April 2, 2019
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)