ComfortNCT02082158
Assessment of Novel Respiratory Protective Devices in Healthcare
A study testing Study Procedures in people with Comfort and Tolerability, run by National Center for Occupational Health and Infection Control at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Comfort, Tolerability
- What is being tested?
- Study Procedures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
About this study
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.
Read the 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.
- Conditions
- Comfort, Tolerability
- Being tested
- Study Procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ProceduresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Local Respirator Model | Active comparator | Subjects randomized to the local respirator model will wear that model while performing study procedures. Receives: Other: Study Procedures |
| Non-Local Respirator Model | Active comparator | Subjects randomized to the non-local respirator design will wear that model while performing study procedures. Receives: Other: Study Procedures |
| Prototype 1 Respirator Design | Experimental | Subjects randomized to the prototype 1 respirator design will wear that model while performing study procedures. Receives: Other: Study Procedures |
| Prototype 2 Respirator Design | Experimental | Subjects randomized to the prototype 2 respirator design will wear that model while performing study procedures. Receives: Other: Study Procedures |
| Prototype 3 Respirator Design | Experimental | Subjects randomized to the prototype 3 respirator design will wear that model while performing study procedures. Receives: Other: Study Procedures |
| Prototype 4 Respirator Design | Experimental | Subjects randomized to the prototype 4 respirator design will wear that model while performing study procedures. Receives: Other: Study Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1
Secondary outcomes (1)
To Collect Healthcare Worker Feedback About Perceived Tolerability 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. 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.
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ComfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Occupational Health and Infection Control
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Lewis J Radonovich, MD, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082158
- Sponsor's protocol ID
- 201300693
- Status last verified
- Oct 2016
- First submitted
- 25 Feb 2014
- Last updated
- 23 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Respiratory Protective Devices in Healthcare
- ClinicalTrials.gov ID
- NCT02082158
- Acronym / sponsor ID
- 201300693
- Conditions
- Comfort, Tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- National Center for Occupational Health and Infection ControlUS federal agency
- Collaborators
- VA Office of Research and Development
- Study start
- Jul 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Posted 23 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Local Respirator Model | Active comparator | Other: Study ProceduresSubjects randomized to the local respirator model will wear that model while performing study procedures. |
| Non-Local Respirator Model | Active comparator | Other: Study ProceduresSubjects randomized to the non-local respirator design will wear that model while performing study procedures. |
| Prototype 1 Respirator Design | Experimental | Other: Study ProceduresSubjects randomized to the prototype 1 respirator design will wear that model while performing study procedures. |
| Prototype 2 Respirator Design | Experimental | Other: Study ProceduresSubjects randomized to the prototype 2 respirator design will wear that model while performing study procedures. |
| Prototype 3 Respirator Design | Experimental | Other: Study ProceduresSubjects randomized to the prototype 3 respirator design will wear that model while performing study procedures. |
| Prototype 4 Respirator Design | Experimental | Other: Study ProceduresSubjects randomized to the prototype 4 respirator design will wear that model while performing study procedures. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study ProceduresStudy 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. | Other | Local Respirator Model, Non-Local Respirator Model, Prototype 1 Respirator Design, Prototype 2 Respirator Design, Prototype 3 Respirator Design, Prototype 4 Respirator Design |
Primary outcome
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.
1 secondary outcome
To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs
Time frame: Visit 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis J Radonovich, MD principal investigator
US Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Procedures in people with Comfort and Tolerability, run by National Center for Occupational Health and Infection Control at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs (time frame: Visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.