Assessment of Novel Respiratory Protective Devices in Healthcare

• Sponsor: National Center for Occupational Health and Infection Control (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02082158
• Collaborator: VA Office of Research and Development (U.S. Fed)
• Enrollment: 382
• Location: 1
• Arms: 6
• Duration (Months): 10
• Patients Per Site Per Month: 38.2

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Jul 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Lewis J Radonovich, MD, US Department of Veterans Affairs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Center for Occupational Health and Infection Control
• ClinicalTrials.gov Identifier: NCT02082158
• Other Study ID Numbers: 201300693
• First Posted: Mar 10, 2014
• Last Update Posted: Nov 23, 2016
• Last Verified: Oct 1, 2016

Study Results

Participant Flow

Pre-assignment Detail	This study compares multiple respirators using same intervention (study activities). All subjects that pass fit-testing move on to intervention.

Arm/Group Title	Local Respirator Model	Non-Local Respirator Model	Prototype 1 Respirator Design	Prototype 2 Respirator Design	Prototype 3 Respirator Design	Prototype 4 Respirator Design
Arm/Group Description	Subjects randomized to the local respirator model will wear that model while participating in study activities. Local 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	Subjects randomized to the non-local respirator design will wear that model while participating in study activities. Non-Local 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	Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities. Prototype 1 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.	Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities. Prototype 2 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.	Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities. Prototype 3 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.	Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities. Prototype 4 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.
Period Title: Overall Study
STARTED	66	61	52	72	68	63
COMPLETED	58	53	38	68	64	56
NOT COMPLETED	8	8	14	4	4	7

Baseline Characteristics

Arm/Group Title	Local Respirator Model	Non-Local Respirator Model	Prototype 1 Respirator Design	Prototype 2 Respirator Design	Prototype 3 Respirator Design	Prototype 4 Respirator Design	Total
Arm/Group Description	Subjects randomized to a current respirator model will wear that model while participating in study activities. 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.	Subjects randomized to a current respirator design will wear that model while participating in study activities. 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.	Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: 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.	Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: 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.	Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: 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.	Subjects randomized to a novel respirator design will wear that model while participating in study activities. Novel Respirator Design: 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.	Total of all reporting groups
Overall Participants	58	53	38	68	64	56	337
Age (participants) [Number]
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	56 96.6%	53 100%	37 97.4%	68 100%	62 96.9%	55 98.2%	331 98.2%
>=65 years	1 1.7%	0 0%	1 2.6%	0 0%	2 3.1%	1 1.8%	5 1.5%
Sex: Female, Male (Count of Participants)
Female	48 82.8%	37 69.8%	32 84.2%	51 75%	44 68.8%	37 66.1%	249 73.9%
Male	10 17.2%	16 30.2%	6 15.8%	17 25%	20 31.3%	19 33.9%	88 26.1%

Outcome Measures

1. Primary Outcome

Title	To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs
Description	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.
Time Frame	Visit 1

Outcome Measure Data

Analysis Population Description

Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.

Arm/Group Title	Local Respirator Model	Non-Local Respirator Model	Prototype 1 Respirator Design	Prototype 2 Respirator Design	Prototype 3 Respirator Design	Prototype 4 Respirator Design
Arm/Group Description	Subjects randomized to the local respirator model will wear that model while participating in study activities. 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.	Subjects randomized to the non-local respirator model will wear that model while participating in study activities. 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.	Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities. 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.	Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities. 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.	Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities. 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.	Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities. 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.
Measure Participants	58	53	38	68	64	56
Discomfort	5.0 (3.8)	4.6 (3.6)	3.7 (2.8)	4.0 (3.1)	3.3 (2.5)	3.1 (2.8)
Wearing	1.4 (1.8)	1.1 (1.5)	0.7 (1.0)	1.1 (1.8)	0.7 (1.3)	0.9 (1.4)

2. Secondary Outcome

Title	To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs
Description	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.
Time Frame	Visit 1

Outcome Measure Data

Analysis Population Description

Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.

Arm/Group Title	Local Respirator Model	Non-Local Respirator Model	Prototype 1 Respirator Design	Prototype 2 Respirator Design	Prototype 3 Respirator Design	Prototype 4 Respirator Design
Arm/Group Description	Subjects randomized to a current respirator model will wear that model while participating in study activities. Local 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	Subjects randomized to a non-local respirator model will wear that model while participating in study activities. Non-Local 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	Subjects randomized to a novel respirator design will wear that respirator while participating in study activities. Prototype 1 Respirator Design: 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.	Subjects randomized to a novel respirator design will wear that respirator while participating in study activities. Prototype 2 Respirator Design: 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.	Subjects randomized to a novel respirator design will wear that respirator while participating in study activities. Prototype 3 Respirator Design: 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.	Subjects randomized to a novel respirator design will wear that respirator while participating in study activities. Prototype 4 Respirator Design: 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.
Measure Participants	58	53	38	68	64	56
Mean (Standard Deviation) [units on a scale]	9.4 (7.5)	8.3 (6.3)	5.8 (4.5)	7.6 (6.4)	6.1 (4.9)	5.7 (4.4)

Adverse Events

Arm/Group Title	Local Respirator Model		Non-Local Respirator Model		Prototype 1 Respirator Design		Prototype 2 Respirator Design		Prototype 3 Respirator Design		Prototype 4 Respirator Design
Arm/Group Description	Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.		Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.		Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.		Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.		Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.		Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
All Cause Mortality
	Local Respirator Model		Non-Local Respirator Model		Prototype 1 Respirator Design		Prototype 2 Respirator Design		Prototype 3 Respirator Design		Prototype 4 Respirator Design
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Local Respirator Model		Non-Local Respirator Model		Prototype 1 Respirator Design		Prototype 2 Respirator Design		Prototype 3 Respirator Design		Prototype 4 Respirator Design
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/61 (0%)		0/52 (0%)		0/72 (0%)		0/68 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Local Respirator Model		Non-Local Respirator Model		Prototype 1 Respirator Design		Prototype 2 Respirator Design		Prototype 3 Respirator Design		Prototype 4 Respirator Design
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/61 (0%)		0/52 (0%)		0/72 (0%)		1/68 (1.5%)		0/63 (0%)
Psychiatric disorders
Panic related to claustrophobia	0/66 (0%)	0	0/61 (0%)	0	0/52 (0%)	0	0/72 (0%)	0	1/68 (1.5%)	1	0/63 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.