Emergency MedicineReuseN95NCT05148793
N95 Reuse During COVID-19
An observational study of Emergency Medicine and Frontline Providers, run by University of California, San Francisco at 1 site in United States.
Trial summary
During critical personal protective equipment (PPE) shortages, such as those associated with the COVID-19 pandemic, Centers for Disease Control (CDC) recommends N95 extended use (wearing the same N95 for multiple patient encounters) and limited reuse (storing an N95 between shifts for use over multiple shifts with or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Medicine, Frontline Providers, Healthcare Worker
- How many people
- 412 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare provider, specifically frontline workers that involves direct patient contact.
Who may be able to join
- Adult (18 years old or greater)
- ED providers (MDs, nurses, Advanced Practice Providers (APPs)) who are practicing extended use and re-use for the majority (more than half) of their shifts Participants are eligible when obtaining a new N95 and are scheduled to work a minimum of 5 shifts within a 60-day period. As hours of enrollment and data collection depend on research associate availability, participants working certain shifts may not be eligible.
Who cannot join
- Participant does not intend to use N95 for majority of shift
- Schedule prohibits re-use and or data collection
- Repeated failed baseline fit test
- Refused or unable to consent
- Pregnant
- Facial hair (e.g., beards or sideburns) or jewelry which interferes with the face seal region of an N95
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Clinical Examination of N95 Reuse and Extended Use
During critical personal protective equipment (PPE) shortages, such as those associated with the COVID-19 pandemic, Centers for Disease Control (CDC) recommends N95 extended use (wearing the same N95 for multiple patient encounters) and limited reuse (storing an N95 between shifts for use over multiple shifts with or without decontamination) as contingency and crisis capacity strategies, respectively. Many healthcare workers (HCWs) are employing these strategies out of necessity. The sustained performance of these respirators depends on the respirator maintaining its filtration efficiency and its ability to provide an adequate seal (fit) to the user's face. Fit testing is performed when a respirator is issued to the user and on an annual basis thereafter. A user-seal check is then performed whenever a respirator is donned. Previous studies have found repeated donnings/doffings to significantly decrease the respirator's fit. A recent pilot cross-sectional clinical study conducted by the University of California, San Francisco found fit failures of respirators after being worn for 2 shifts. However, more definitive data regarding respirator performance during reuse and extended use are lacking. The investigators plan to address these critical gaps in knowledge by conducting a prospective cohort study to determine the incidence of N95 fit failure when subjected to extended use/reuse in a clinical setting. The investigators plan to enroll 396 ED providers (including physicians, nurses, and staff) when obtaining a new NIOSH approved N95s and performing serial fit tests at the end of each 8-12 hour shift for up to 5 clinical shifts or until N95 failure, whichever is earlier. By carefully measuring fit test failure in a clinical setting, the investigators will be able to provide guidance regarding the safety of N95 extended use and reuse necessitated by the need for PPE conservation. Specifically, the investigators will address the following research questions: 1) how long N95s maintain their fit during extended use, 2) how many times N95s can be donned/doffed and maintain their fit, 3) the ability of a user seal check to indicate fit in the field, 4) what adverse health effects, reports of discomfort, or symptoms are experienced by users during extended use and reuse, 5) what effect does extended use and reuse have on N95 filtration performance, 6) the level of contamination of N95s when subjected to extended use and reuse, 7) the effect of modifications to N95 (covering an N95 with a face shield or surgical N95s, facial coverings) on fit failure.
Read the detailed description
Frontline healthcare workers are at high risk of SARS (severe acute respiratory syndrome) CoV-2 (COVID-19) infection. Personal protective equipment (PPE), such as an N95 respirator (N95), is essential for prevention of COVID-19 among HCWs. N95s can prevent aerosolized transmission of viral particles and reduce COVID-19 among HCWs, helping to reduce infection rates and preserve the workforce. Under normal circumstances, the CDC recommends that HCWs dispose of N95s after a single patient encounter. However, during critical PPE shortages such as those during the current COVID-19 pandemic, the CDC recommends N95 extended use (wearing the same N95 for multiple patient encounters) and re-use (storing an N95 between shifts for use over multiple shifts). N95 shortages have been widely reported during the COVID-19 pandemic and have forced HCWs to practice extended use and reuse of N95s. Despite the CDC's guidelines, there are limited data regarding the efficacy of N95s under conditions of extended use and reuse and existing studies have been conducted in laboratory settings rather than in the actual health care environment. (Bergman 2012; Vuma et al 2019). This has left health care workers, including emergency department (ED) providers on the front lines of the COVID-19 pandemic, without clear guidance regarding N95 conservation. Many have implemented various reuse and extended use policies out of necessity but with no empirical evidence of their safety and effectiveness.
The study team conducted a pilot cross-sectional study of 68 ED providers who wore either a 3M 1860 dome style N95 or a duckbill N951. 70.6% of duckbill N95 failed a standardized fit test with 3M bitter solution and a hood. Of the dome style , 27.5% failed a fit test. N95 failure was associated with increasing numbers of shifts used: There were 0/11 failures after 1 shift, 1/12 failures after 2 shifts, 3/13 failures after 3 shifts, and 10/15 failures after 4 or more shifts. Also, more donnings and doffings were associated with fit failure, with a median of 8 donning and doffings in the fit pass group and 15 donning and doffings in the fit failure group. This preliminary study had a number of limitations, including a small sample size, convenience sampling, and cross-sectional design, and so was unable to definitively identify the number of shifts or donnings/doffings for which N95s can be safely reused.
The investigators propose to conduct a prospective cohort study of 396 participants across 6 ED sites to estimate the cumulative incidence of N95s when subjected to extended use and reuse in a clinical (emergency department) setting with fit test failure and contamination as the main endpoints. The investigators also seek to compare the fit test failure between varying types of HCWs wearing a number of N95 types. Additionally, the investigators will collect the N95s used in this study for additional analyses of at an outside laboratory measuring COVID-19 contamination levels and filtration efficiency.
- Conditions
- Emergency Medicine, Frontline Providers, Healthcare Worker
- Keywords
- N95 mask, Personal Protective Equipment, Extended use, reuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with qualitative fit test failure (N95 A, end of shift 1)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 1, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift A1, up to 12 hours
Number of participants with qualitative fit test failure (N95 A, end of shift 2)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 2, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift A2, up to 12 hours per shift, 24 hours maximum
Number of participants with qualitative fit test failure (N95 A, end of shift 3)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 3, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift A3, up to 12 hours per shift, 36 hours maximum
Number of participants with qualitative fit test failure (N95 A, end of shift 4)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 4, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift A4, up to 12 hours per shift, 48 hours maximum
Number of participants with qualitative fit test failure (N95 A, end of shift 5)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 5, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift A5, up to 12 hours per shift, 60 hours maximum
Number of participants with qualitative fit test failure (N95 B, end of shift 1)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 1, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift B1, up to 12 hours maximum
Number of participants with qualitative fit test failure (N95 B, end of shift 2)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 2, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift B2, up to 12 hours per shift, 24 hours maximum
Number of participants with qualitative fit test failure (N95 B, end of shift 3)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 3, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift B3, up to 12 hours per shift, 36 hours maximum
Number of participants with qualitative fit test failure (N95 B, end of shift 4)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 4, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift B4, up to 12 hours per shift, 48 hours maximum
Number of participants with qualitative fit test failure (N95 B, end of shift 5)
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 5, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Measured: At the end of shift B5, up to 12 hours per shift, 60 hours maximum
Secondary outcomes (10)
Number of participants with User Seal Check failure (N95 A, end of shift 1)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given facial filtering respirator (FFR) develops an acceptable "leak-free" seal with a subject's face. A user seal check (USC) is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research Clinical Research Coordinator (CRC) will record whether the user seal check indicates a good seal.
Measured: At the end of shift A1, up to 12 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 2)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift A2, up to 12 hours per shift, 24 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 3)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift A3, up to 12 hours per shift, 36 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 4)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift A4, up to 12 hours per shift, 48 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 5)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift A5, up to 12 hours per shift, 60 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 1)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift B1, up to 12 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 2)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift B2, up to 12 hours per shift, 24 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 3)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift B3, up to 12 hours per shift, 36 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 4)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift B4, up to 12 hours per shift, 48 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 5)
Participants will be asked to perform a brief "self- test" occurring prior to an actual fit test to determine that a given FFR develops an acceptable "leak-free" seal with a subject's face. A USC is subjective and determines whether the participant feels that the respirator seals well enough with the participant's face to proceed forward with the actual fit test. The research CRC will record whether the user seal check indicates a good seal.
Measured: At the end of shift B5, up to 12 hours per shift, 60 hours maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Johns Hopkins University, University of Wisconsin, Madison, Emory University, University of Rochester, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Maria C Raven, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148793
- Sponsor's protocol ID
- 21-33232
- Acronym
- ReuseN95
- Status last verified
- Feb 2023
- First submitted
- 6 Dec 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Examination of N95 Reuse and Extended Use
- ClinicalTrials.gov ID
- NCT05148793
- Acronym / sponsor ID
- ReuseN95 / 21-33232
- Conditions
- Emergency Medicine, Frontline Providers, Healthcare Worker
- Keywords
- N95 mask, Personal Protective Equipment, Extended use, reuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, San Diego, Johns Hopkins University, University of Wisconsin, Madison, Emory University, University of Rochester, Centers for Disease Control and Prevention
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During critical personal protective equipment (PPE) shortages, such as those associated with the COVID-19 pandemic, Centers for Disease Control (CDC) recommends N95 extended use (wearing the same N95 for multiple patient encounters) and limited reuse (storing an N95 between shifts for use over multiple shifts with or without decontamination) as contingency and crisis capacity strategies, respectively. Many healthcare workers (HCWs) are employing these strategies out of necessity. The sustained performance of these respirators depends on the respirator maintaining its filtration efficiency and its ability to provide an adequate seal (fit) to the user's face. Fit testing is performed when a respirator is issued to the user and on an annual basis thereafter. A user-seal check is then performed whenever a respirator is donned. Previous studies have found repeated donnings/doffings to significantly decrease the respirator's fit. A recent pilot cross-sectional clinical study conducted by the University of California, San Francisco found fit failures of respirators after being worn for 2 shifts. However, more definitive data regarding respirator performance during reuse and extended use are lacking. The investigators plan to address these critical gaps in knowledge by conducting a prospective cohort study to determine the incidence of N95 fit failure when subjected to extended use/reuse in a clinical setting. The investigators plan to enroll 396 ED providers (including physicians, nurses, and staff) when obtaining a new NIOSH approved N95s and performing serial fit tests at the end of each 8-12 hour shift for up to 5 clinical shifts or until N95 failure, whichever is earlier. By carefully measuring fit test failure in a clinical setting, the investigators will be able to provide guidance regarding the safety of N95 extended use and reuse necessitated by the need for PPE conservation. Specifically, the investigators will address the following research questions: 1) how long N95s maintain their fit during extended use, 2) how many times N95s can be donned/doffed and maintain their fit, 3) the ability of a user seal check to indicate fit in the field, 4) what adverse health effects, reports of discomfort, or symptoms are experienced by users during extended use and reuse, 5) what effect does extended use and reuse have on N95 filtration performance, 6) the level of contamination of N95s when subjected to extended use and reuse, 7) the effect of modifications to N95 (covering an N95 with a face shield or surgical N95s, facial coverings) on fit failure.
Detailed description
Frontline healthcare workers are at high risk of SARS (severe acute respiratory syndrome) CoV-2 (COVID-19) infection. Personal protective equipment (PPE), such as an N95 respirator (N95), is essential for prevention of COVID-19 among HCWs. N95s can prevent aerosolized transmission of viral particles and reduce COVID-19 among HCWs, helping to reduce infection rates and preserve the workforce. Under normal circumstances, the CDC recommends that HCWs dispose of N95s after a single patient encounter. However, during critical PPE shortages such as those during the current COVID-19 pandemic, the CDC recommends N95 extended use (wearing the same N95 for multiple patient encounters) and re-use (storing an N95 between shifts for use over multiple shifts). N95 shortages have been widely reported during the COVID-19 pandemic and have forced HCWs to practice extended use and reuse of N95s. Despite the CDC's guidelines, there are limited data regarding the efficacy of N95s under conditions of extended use and reuse and existing studies have been conducted in laboratory settings rather than in the actual health care environment. (Bergman 2012; Vuma et al 2019). This has left health care workers, including emergency department (ED) providers on the front lines of the COVID-19 pandemic, without clear guidance regarding N95 conservation. Many have implemented various reuse and extended use policies out of necessity but with no empirical evidence of their safety and effectiveness.
The study team conducted a pilot cross-sectional study of 68 ED providers who wore either a 3M 1860 dome style N95 or a duckbill N951. 70.6% of duckbill N95 failed a standardized fit test with 3M bitter solution and a hood. Of the dome style , 27.5% failed a fit test. N95 failure was associated with increasing numbers of shifts used: There were 0/11 failures after 1 shift, 1/12 failures after 2 shifts, 3/13 failures after 3 shifts, and 10/15 failures after 4 or more shifts. Also, more donnings and doffings were associated with fit failure, with a median of 8 donning and doffings in the fit pass group and 15 donning and doffings in the fit failure group. This preliminary study had a number of limitations, including a small sample size, convenience sampling, and cross-sectional design, and so was unable to definitively identify the number of shifts or donnings/doffings for which N95s can be safely reused.
The investigators propose to conduct a prospective cohort study of 396 participants across 6 ED sites to estimate the cumulative incidence of N95s when subjected to extended use and reuse in a clinical (emergency department) setting with fit test failure and contamination as the main endpoints. The investigators also seek to compare the fit test failure between varying types of HCWs wearing a number of N95 types. Additionally, the investigators will collect the N95s used in this study for additional analyses of at an outside laboratory measuring COVID-19 contamination levels and filtration efficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare provider, specifically frontline workers that involves direct patient contact.
Key inclusion criteria (2 listed)
- Adult (18 years old or greater)
- ED providers (MDs, nurses, Advanced Practice Providers (APPs)) who are practicing extended use and re-use for the majority (more than half) of their shifts Participants are eligible when obtaining a new N95 and are scheduled to work a minimum of 5 shifts within a 60-day period. As hours of enrollment and data collection depend on research associate availability, participants working certain shifts may not be eligible.
Key exclusion criteria (6 listed)
- Participant does not intend to use N95 for majority of shift
- Schedule prohibits re-use and or data collection
- Repeated failed baseline fit test
- Refused or unable to consent
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with qualitative fit test failure (N95 A, end of shift 1)
Time frame: At the end of shift A1, up to 12 hours
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 1, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 A, end of shift 2)
Time frame: At the end of shift A2, up to 12 hours per shift, 24 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 2, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 A, end of shift 3)
Time frame: At the end of shift A3, up to 12 hours per shift, 36 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 3, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 A, end of shift 4)
Time frame: At the end of shift A4, up to 12 hours per shift, 48 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 4, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 A, end of shift 5)
Time frame: At the end of shift A5, up to 12 hours per shift, 60 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 5, for N95 A. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 B, end of shift 1)
Time frame: At the end of shift B1, up to 12 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 1, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 B, end of shift 2)
Time frame: At the end of shift B2, up to 12 hours per shift, 24 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 2, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 B, end of shift 3)
Time frame: At the end of shift B3, up to 12 hours per shift, 36 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 3, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 B, end of shift 4)
Time frame: At the end of shift B4, up to 12 hours per shift, 48 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 4, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
Number of participants with qualitative fit test failure (N95 B, end of shift 5)
Time frame: At the end of shift B5, up to 12 hours per shift, 60 hours maximum
Qualitative fit test outcome is measured by a trained fit tester at the end of participant shift 5, for N95 B. The fit test is performed up to 5 times per N95 or until fit test failure. The fit tester records whether the N95 passed fit testing (Yes or No). The fit test variable outcome indicates a passed fit test (yes) or failed fit test (no).
10 secondary outcomes
Number of participants with User Seal Check failure (N95 A, end of shift 1)
Time frame: At the end of shift A1, up to 12 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 2)
Time frame: At the end of shift A2, up to 12 hours per shift, 24 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 3)
Time frame: At the end of shift A3, up to 12 hours per shift, 36 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 4)
Time frame: At the end of shift A4, up to 12 hours per shift, 48 hours maximum
Number of participants with User Seal Check failure (N95 A, end of shift 5)
Time frame: At the end of shift A5, up to 12 hours per shift, 60 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 1)
Time frame: At the end of shift B1, up to 12 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 2)
Time frame: At the end of shift B2, up to 12 hours per shift, 24 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 3)
Time frame: At the end of shift B3, up to 12 hours per shift, 36 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 4)
Time frame: At the end of shift B4, up to 12 hours per shift, 48 hours maximum
Number of participants with User Seal Check failure (N95 B, end of shift 5)
Time frame: At the end of shift B5, up to 12 hours per shift, 60 hours maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. The investigators will not share individual participant data.
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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.
Maria C Raven, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Medicine and Frontline Providers, run by University of California, San Francisco 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 2 inclusion and 6 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 16 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with qualitative fit test failure (N95 A, end of shift 1) (time frame: At the end of shift A1, up to 12 hours). The study lists 10 primary outcomes in all. 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 16 Feb 2023.