Assessment of Novel Respiratory Protective Devices in Healthcare
1 other identifier
interventional
382
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
November 23, 2016
CompletedNovember 23, 2016
October 1, 2016
10 months
February 25, 2014
June 7, 2016
October 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs
Visit 1
Study Arms (6)
Local Respirator Model
ACTIVE COMPARATORSubjects randomized to the local respirator model will wear that model while performing study procedures.
Non-Local Respirator Model
ACTIVE COMPARATORSubjects randomized to the non-local respirator design will wear that model while performing study procedures.
Prototype 1 Respirator Design
EXPERIMENTALSubjects randomized to the prototype 1 respirator design will wear that model while performing study procedures.
Prototype 2 Respirator Design
EXPERIMENTALSubjects randomized to the prototype 2 respirator design will wear that model while performing study procedures.
Prototype 3 Respirator Design
EXPERIMENTALSubjects randomized to the prototype 3 respirator design will wear that model while performing study procedures.
Prototype 4 Respirator Design
EXPERIMENTALSubjects randomized to the prototype 4 respirator design will wear that model while performing study procedures.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Malcom Randall VA Medical Center
Gainesville, Florida, 32608, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aaron Eagan
- Organization
- National Center for Occupational Health and Infection Control
Study Officials
- PRINCIPAL INVESTIGATOR
Lewis J Radonovich, MD
US Department of Veterans Affairs
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2014
First Posted
March 10, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
November 23, 2016
Results First Posted
November 23, 2016
Record last verified: 2016-10