The new silicone elastometric half-piece respirator, VJR-NMU: A novel and effective tool to prevent COVID-19

  1. Anan Manomaipiboon
  2. Sujaree Pupipatpab
  3. Pongsathorn Chomdee
  4. Anusang Chitsomkasem
  5. Yutthana Apichatbutr
  6. Pathiporn Boonyapatkul
  7. Thananda Trakarnvanich

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Abstract

Filter facepiece respirators (FFRs) are critical for preventing the transmission of respiratory tract infection disease, especially the dreadful coronavirus 2 (SARs-CoV-2). The N95 mask is a prototype, high-efficiency protective device that can effectively protect against airborne pathogens of less than 0.3 μm. The N95 mask is tightly fitting and has high filtration capacity. The ongoing COVID-19 pandemic has led to a greater requirement for FFR. This rising demand greatly exceeds current production capabilities and stockpiles, resulting in shortages. To address this, our team has invented a new type of half-piece respirator made from silicone and assembled with HEPA or elastostatic filter. A variety of methods have been used to evaluate this new device, including a qualitative fit test with the Bitrex ® test kit and filtration test. The preliminary results showed that the new elastometric respirators pass the fit test. The filtration tests also confirmed the superiority of the new respirator over traditional N95 masks, with a mean performance of protection greater than 95%. For the filters, we used two types: SafeStar, which is a kind of HEPA filter; and CareStar, which is considered an elastostatic filler. CareStar was developed to filter virus and bacteria in the operating room, with a limit duration of use up to 24 h, while the safe star was designed for 72 h use and has the quality equivalent to a HEPA filter. Our study demonstrated superior filtration efficacy of both filters, more than 98% even after 24 h of use. CareStar has significantly more filtration efficacy than a safe star (p < 0.001). In conclusion, the development of our new N99 half-piece respirator should ultimately be applicable to healthcare workers with at least non-inferiority to the previously used N 95 respirators. As a universal masking policy is generally implemented, health care workers who are at risk must be protected with appropriate devices. Currently, the adequate supply of such equipment is not feasible. The advent of the new protective device will help protect healthcare workers and replenish the shortage of N95 respirators during the COVID-19 pandemic.

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  1. Version published to 10.1371/journal.pone.0237206
  2. ScreenIT

    SciScore for 10.1101/2020.07.23.217372: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The Vajira Institutional Review Board, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, approved the protocol, and all participants provided informed consent.
    Consent: The Vajira Institutional Review Board, Faculty of Medicine, Vajira Hospital, Navamindradhiraj University, approved the protocol, and all participants provided informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableForty-three people (22 males, 21 females; mean age 28.71 ± 7.04 years) participated in this study.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data collection: Data analysis: The data analysis was performed using SPSS version 22.0 and Microsoft Office Excel for presenting the demographic data and respirator size.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    Microsoft Office Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • No conflict of interest statement was detected. If there are no conflicts, we encourage authors to explicit state so.
    • No funding statement was detected.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.07.23.217372v1 on bioRxiv