Assessment of Novel Respiratory Protective Devices in Healthcare

National Center for Occupational Health and Infection Control

Status: Completed

Conditions: Tolerability; Comfort

Treatments: Other: Study Procedures

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02082158

201300693

Details and patient eligibility

About

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.

Full 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.

Enrollment: 382 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

382 participants in 6 patient groups

Local Respirator Model

Active Comparator group

Description:

Subjects randomized to the local respirator model will wear that model while performing study procedures.

Treatment:

Other: Study Procedures

Non-Local Respirator Model

Active Comparator group

Description:

Subjects randomized to the non-local respirator design will wear that model while performing study procedures.

Treatment:

Other: Study Procedures

Prototype 1 Respirator Design

Experimental group

Description:

Subjects randomized to the prototype 1 respirator design will wear that model while performing study procedures.

Treatment:

Other: Study Procedures

Prototype 2 Respirator Design

Experimental group

Description:

Subjects randomized to the prototype 2 respirator design will wear that model while performing study procedures.

Treatment:

Other: Study Procedures

Prototype 3 Respirator Design

Experimental group

Description:

Subjects randomized to the prototype 3 respirator design will wear that model while performing study procedures.

Treatment:

Other: Study Procedures

Prototype 4 Respirator Design

Experimental group

Description:

Subjects randomized to the prototype 4 respirator design will wear that model while performing study procedures.

Treatment:

Other: Study Procedures