Assessment of Novel Respiratory Protective Devices in Healthcare

Completed · Not applicable

Conditions studied: Comfort, Tolerability

In brief

This VA-based study will obtain feedback from healthcare workers via validated survey instrument on the comfort and tolerability of wearing current models of N95 respirators and novel respirator designs currently in development. There will be 4 novel respirators and 1 commonly used respirator (not locally used) to compare to a locally used respirator, which is familiar to participants. Comparisons will be examined between each of the first 5 models with the locally used control using Dunnett's t-test.

Key facts

Study ID

NCT02082158

Run by

National Center for Occupational Health and Infection Control

People needed

382

Starts

2014-07-01

Expected to finish

2015-05-01

Last updated by the study team

2016-11-23

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• VA or UF Health Shands Hospital clinical healthcare worker
• Has been previously fit-tested to a N95 respirator
• Is able to pass fit-testing on the model of respirator he/she is randomized to

You may not qualify if…

• Does not meet study inclusion criteria
• Is pregnant
• Has a health condition that prevents him/her from wearing a respirator
• Has physical characteristics that may interfere with his/her ability to attain an adequate facial seal when fit-tested (e.g. growth of facial hair, facial scarring)
• Has any condition which could, in the opinion of the investigator, place the participant at risk or interfere with data integrity. This includes a previous reaction to inhalation of both the Bitrex or saccharin solution used during fit-testing procedures.

Where it is running

• Malcom Randall VA Medical Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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