Clinical trial NCT02082158: Assessment of Novel Respiratory Protective Devices in Healthcare
Official title: Assessment of Novel Respiratory Protective Devices in Healthcare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comfort
Tolerability
Lead sponsor: National Center for Occupational Health and Infection Control
Sponsor class: FED
Collaborators: name: VA Office of Research and Development
First posted: 2014-03-10
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: This study aims to compare novel designs to products currently in the marketplace by comparing scores on a survey tool which measures comfort and tolerability of respiratory protective devices. Study participants will be clinical healthcare workers who have experience wearing respiratory protective devices in their workplace. We will enroll up to 400 participants in the study, made up of physicians, nurses, nursing assistants and other healthcare employees who have previously been fit-tested to a N95 respirator. Subjects will be screened to determine eligibility and must pass fit-testing on the respirator he/she is randomized to. Participants will wear the respirator while performing a series of motions that simulate movements made by healthcare workers when performing patient care tasks. There will be no contact with patients during participation. Feedback via validated survey tool will be collected from all study participants on the comfort and tolerability of the respirator worn.

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.

Primary outcomes:
measure: To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs
timeFrame: Visit 1
Secondary outcomes:
measure: To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs
timeFrame: Visit 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
Study officials:
affiliation: US Department of Veterans Affairs
name: Lewis J Radonovich, MD
role: PRINCIPAL_INVESTIGATOR
References: