Just-in-time Elastomeric Training and Fit Testing (JET FIT)
Completed · Not applicable
Conditions studied: Infection
In brief
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.
Key facts
- Study ID
- NCT03888898
- Run by
- Centers for Disease Control and Prevention
- People needed
- 300
- Starts
- 2019-04-02
- Expected to finish
- 2021-02-01
- Last updated by the study team
- 2023-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Emory University — Atlanta, Georgia, United States
- Wayne State University — Detroit, Michigan, United States
- University of Texas — Houston, Texas, United States
Full record on ClinicalTrials.gov
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