Assessment of Novel Respiratory Protective Devices in Healthcare

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Novel Respiratory Protective Devices in Healthcare

Conditions
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Comfort, Tolerability

Intervention / Treatment
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* Other: Study Procedures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local Respirator Model<br>Subjects randomized to the local respirator model will wear that model while performing study procedures. | Other: Study Procedures<br>* Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.<br>|
| Active Comparator: Non-Local Respirator Model<br>Subjects randomized to the non-local respirator design will wear that model while performing study procedures. | Other: Study Procedures<br>* Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.<br>|
| Experimental: Prototype 1 Respirator Design<br>Subjects randomized to the prototype 1 respirator design will wear that model while performing study procedures. | Other: Study Procedures<br>* Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.<br>|
| Experimental: Prototype 2 Respirator Design<br>Subjects randomized to the prototype 2 respirator design will wear that model while performing study procedures. | Other: Study Procedures<br>* Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.<br>|
| Experimental: Prototype 3 Respirator Design<br>Subjects randomized to the prototype 3 respirator design will wear that model while performing study procedures. | Other: Study Procedures<br>* Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.<br>|
| Experimental: Prototype 4 Respirator Design<br>Subjects randomized to the prototype 4 respirator design will wear that model while performing study procedures. | Other: Study Procedures<br>* Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs | Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, 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. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator. | Visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Collect Healthcare Worker Feedback About Perceived Tolerability 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. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator. | Visit 1 |