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NCT05148793 · ClinicalTrials.gov registry record
N95 Reuse During COVID-19
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 412
- Enrollment target
NCT05148793: Completed study, sponsored by University of California, San Francisco.
NCT05148793 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 412 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05148793 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 412 participants
- Enrollment target
Study 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
Primary Outcome
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2022-12-31 |
What the finished NCT05148793 record still lists
NCT05148793 is an observational study that tracks outcomes without assigning an intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT05148793 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05148793 about?
NCT05148793 is a clinical study titled "N95 Reuse During COVID-19". 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 multi...
What is the current status of trial NCT05148793?
This trial is currently completed. The enrollment target is 412 participants. The study started on 2021-04-01. Estimated completion is 2022-12-31.
Who is sponsoring clinical trial NCT05148793?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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