Assessment of Novel Respiratory Protective Devices in Healthcare

Comfort Clinical Trial

Official title: Assessment of Novel Respiratory Protective Devices in Healthcare

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Comfort
• Tolerability

• NCT number: NCT02082158
• Study type: Interventional
• Source: National Center for Occupational Health and Infection Control
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Completion date: May 2015