Tolerability Clinical Trial
Official title:
Assessment of Novel Respiratory Protective Devices in Healthcare
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.
Status | Completed |
Enrollment | 383 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Malcom Randall VA Medical Center | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
National Center for Occupational Health and Infection Control | VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To collect healthcare worker feedback about perceived comfort of novel respirator designs | Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. | Visit 1 | No |
Secondary | To collect healthcare worker feedback about perceived tolerability of novel respirator designs | Subjects will answer questions concerning tolerability of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. | Visit 1 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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