N95 Reuse During COVID-19

NCT05148793 | Completed

• 1 other identifier: 21-33232
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Emergency Medicine; Frontline Providers; Healthcare Worker

Keywords

N95 mask; Personal Protective Equipment; Extended use; reuse

Outcome Measures

Primary Outcomes (10)

• 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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)

  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)

  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)

  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)

  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)

  At the end of shift A5, up to 12 hours per shift, 60 hours maximum

Other Outcomes (358)

• Number of participants with qualitative fit test failure of Mask A (at Baseline)

  Prior to study inclusion

• N95 B Outcome

  Within 6 months of enrollment

• N95 A Outcome

  Within 6 months of enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthcare provider, specifically frontline workers that involves direct patient contact.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, San Diego: collaborator
• Johns Hopkins University: collaborator
• University of Wisconsin, Madison: collaborator
• Emory University: collaborator
• University of Rochester: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Study Officials

• Maria C Raven, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 8, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)