Trial Outcomes & Findings for Assessment of Novel Respiratory Protective Devices in Healthcare (NCT NCT02082158)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

382 participants

Primary outcome timeframe

Visit 1

Results posted on

2016-11-23

Participant Flow

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

Participant milestones

Participant milestones
Measure	Local Respirator Model 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	Non-Local Respirator Model 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	Prototype 1 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.	Prototype 2 Respirator Design 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.	Prototype 3 Respirator Design 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.	Prototype 4 Respirator Design 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.
Overall Study STARTED	66	61	52	72	68	63
Overall Study COMPLETED	58	53	38	68	64	56
Overall Study NOT COMPLETED	8	8	14	4	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Local Respirator Model 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	Non-Local Respirator Model 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	Prototype 1 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.	Prototype 2 Respirator Design 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.	Prototype 3 Respirator Design 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.	Prototype 4 Respirator Design 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.
Overall Study Withdrawal by Subject	0	0	0	0	1	0
Overall Study Failed Fit-testing	8	8	14	4	3	7

Baseline Characteristics

Assessment of Novel Respiratory Protective Devices in Healthcare

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Local Respirator Model n=58 Participants 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.	Non-Local Respirator Model n=53 Participants 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.	Prototype 1 Respirator Design n=38 Participants 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.	Prototype 2 Respirator Design n=68 Participants 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.	Prototype 3 Respirator Design n=64 Participants 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.	Prototype 4 Respirator Design n=56 Participants 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 n=337 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=8 Participants	0 participants n=8 Participants
Age, Categorical Between 18 and 65 years	56 participants n=5 Participants	53 participants n=7 Participants	37 participants n=5 Participants	68 participants n=4 Participants	62 participants n=21 Participants	55 participants n=8 Participants	331 participants n=8 Participants
Age, Categorical >=65 years	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants	1 participants n=8 Participants	5 participants n=8 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	37 Participants n=7 Participants	32 Participants n=5 Participants	51 Participants n=4 Participants	44 Participants n=21 Participants	37 Participants n=8 Participants	249 Participants n=8 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants	20 Participants n=21 Participants	19 Participants n=8 Participants	88 Participants n=8 Participants

PRIMARY outcome

Timeframe: Visit 1

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

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.

Outcome measures

Outcome measures
Measure	Local Respirator Model n=58 Participants 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.	Non-Local Respirator Model n=53 Participants 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.	Prototype 1 Respirator Design n=38 Participants 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.	Prototype 2 Respirator Design n=68 Participants 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.	Prototype 3 Respirator Design n=64 Participants 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.	Prototype 4 Respirator Design n=56 Participants 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.
To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs Discomfort	5.0 units on a scale Standard Deviation 3.8	4.6 units on a scale Standard Deviation 3.6	3.7 units on a scale Standard Deviation 2.8	4.0 units on a scale Standard Deviation 3.1	3.3 units on a scale Standard Deviation 2.5	3.1 units on a scale Standard Deviation 2.8
To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs Wearing	1.4 units on a scale Standard Deviation 1.8	1.1 units on a scale Standard Deviation 1.5	0.7 units on a scale Standard Deviation 1.0	1.1 units on a scale Standard Deviation 1.8	0.7 units on a scale Standard Deviation 1.3	0.9 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Visit 1

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

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.