Assessment of Novel Respiratory Protective Devices in Healthcare

Comfort Clinical Trial

Official title:

Assessment of Novel Respiratory Protective Devices in Healthcare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082158
• Other study ID #: 201300693
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: June 15, 2015
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: National Center for Occupational Health and Infection Control
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Comfort
• Tolerability

Intervention

Other:
• Current Respirator Model
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.
• Novel Respirator Design

Locations

Country	Name	City	State
United States	Malcom Randall VA Medical Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Occupational Health and Infection Control	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect healthcare worker feedback about perceived comfort 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.	Visit 1	No
Secondary	To collect healthcare worker feedback about perceived tolerability of novel respirator designs	Subjects will answer questions concerning tolerability 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.	Visit 1	No