Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Novel Respiratory Protective Devices in Healthcare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082158
Recruitment Status : Completed
First Posted : March 10, 2014
Results First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
National Center for Occupational Health and Infection Control

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.

Condition or disease Intervention/treatment Phase
Comfort Tolerability Other: Study Procedures Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Novel Respiratory Protective Devices in Healthcare
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs [ Time Frame: Visit 1 ]
    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.


Secondary Outcome Measures :
  1. To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs [ Time Frame: Visit 1 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082158


Locations
Layout table for location information
United States, Florida
Malcom Randall VA Medical Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
National Center for Occupational Health and Infection Control
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Lewis J Radonovich, MD US Department of Veterans Affairs
Layout table for additonal information
Responsible Party: National Center for Occupational Health and Infection Control
ClinicalTrials.gov Identifier: NCT02082158    
Other Study ID Numbers: 201300693
First Posted: March 10, 2014    Key Record Dates
Results First Posted: November 23, 2016
Last Update Posted: November 23, 2016
Last Verified: October 2016