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.

Study Overview

• Status: Completed
• Conditions: Tolerability; Comfort
• Intervention / Treatment: Other: Study Procedures

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.

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local Respirator Model; Subjects randomized to the local respirator model will wear that model while performing study procedures.	Other: Study Procedures; 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.
Active Comparator: Non-Local Respirator Model; Subjects randomized to the non-local respirator design will wear that model while performing study procedures.	Other: Study Procedures; 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.
Experimental: Prototype 1 Respirator Design; Subjects randomized to the prototype 1 respirator design will wear that model while performing study procedures.	Other: Study Procedures; 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.
Experimental: Prototype 2 Respirator Design; Subjects randomized to the prototype 2 respirator design will wear that model while performing study procedures.	Other: Study Procedures; 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.
Experimental: Prototype 3 Respirator Design; Subjects randomized to the prototype 3 respirator design will wear that model while performing study procedures.	Other: Study Procedures; 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.
Experimental: Prototype 4 Respirator Design; Subjects randomized to the prototype 4 respirator design will wear that model while performing study procedures.	Other: Study Procedures; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Center for Occupational Health and Infection Control
• Collaborators: VA Office of Research and Development
• Investigators: Principal Investigator: Lewis J Radonovich, MD, US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 201300693