N/A
Completed N=382
Assessment of Novel Respiratory Protective Devices in Healthcare
Comfort · Tolerability
Source: ClinicalTrials.gov NCT02082158 ↗
Enrolled (actual)
382
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs — 5.0; 4.6; 3.7; 4.0 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs |
5.0; 4.6; 3.7; 4.0; 3.3; 3.1 | — |
| SECONDARY To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs |
9.4; 8.3; 5.8; 7.6; 6.1; 5.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02082158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.