Verification of two alternative do-it-yourself equipment respirator seal as COVID-19 protection (VADERS-CoV) : a quality assessment pilot study
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Abstract
Background : During the COVID-19 pandemic, healthcare workers were facing shortage in personal protective equipment, especially adequate respirators. Alternative do-it-yourself respirators emerged, without any proof of protection. Objective : Verify seal potential of two alternative respirators compared to a common FFP2 respirator. Design : Quality assessment pilot study. Setting : Tertiary Care Hospital. Participants : Ten anaesthesiology residents. Interventions : Participants performed quantitative face-fit tests (QNFT) with three respirators to evaluate seal. A common FFP2 “duckbill” respirator was used as baseline (control group). Alternatives tested in this study were an anaesthesia face mask and a full-face modified snorkelling mask with a 3D-printed connector, both in conjunction with a breathing system filter. Main outcome : Non-inferior seal performance of the alternatives over FFP2, assessed by calculated QNFT based on measured individual fit factors, as defined by the Occupational Safety and Health Administration. Results :For each respirator a total of 90 individual fit factor measurements were taken. Within the control group, seal failed in 37 (41%) measurements but only in 10 (11%) within the anaesthesia mask group and in 6 (7%) within the snorkelling mask group (P < 0.001 respectively). However, when calculating the final, mean QNFT results, no difference was found between respirators. Successful QNFT were determined for 5 out of 10 participants in the FFP2 group, for 8 in the anaesthesia mask group (P = 0.25) and for 7 in the snorkelling mask group (P = 0.69). Conclusion : Both do-it-yourself respirators successfully pass QNFT and have the potential to provide non inferior seal compared to a common FFP2 respirator. While anaesthesia masks are easily assembled, snorkelling masks must undergo significant but feasible modifications. Our results suggest that those do-it-yourself respirators seem to be viable alternatives for situations when certified respirators are not available but need further investigation for validation. Trial registration: Clinicaltrials.gov identifier: NCT04375774 Key Points : Question: Can alternative do-it-yourself respirators protect wearers from hazardous aerosols? Findings : Our findings demonstrate that do-it-yourself respirators have the potential to provide non-inferior seal as compared to regular FFP2 personal protective equipment. Meaning : Our real-life situational testing provides evidence that do-it-yourself respirators potentially provide sufficient seal to compete with or even outperform conventional FFP2 respirators and that face-fit testing should be a mandatory safety check in healthcare providers.
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SciScore for 10.1101/2020.05.23.20111054: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethical approval for this study (Ethical Committee No. 2020/15AVR/226) was provided by the Ethical Committee of the Cliniques Universitaires Saint-Luc, Brussels,
Consent: After giving informed consent, 10 healthy, volunteer anaesthesiology residents were included.Randomization not detected. Blinding not detected. Power Analysis Further, only a sample size of nine should be enough to verify the supposed sufficient seal in FFP2 described by Ciotti et al.11 (18.3%) and a presumed success rate of 80% with ADR considering a power = 0.8 with a significance level of 0.05. Sex as a biological variable Participants confirmed not to have smoked in the hour before testing … SciScore for 10.1101/2020.05.23.20111054: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: Ethical approval for this study (Ethical Committee No. 2020/15AVR/226) was provided by the Ethical Committee of the Cliniques Universitaires Saint-Luc, Brussels,
Consent: After giving informed consent, 10 healthy, volunteer anaesthesiology residents were included.Randomization not detected. Blinding not detected. Power Analysis Further, only a sample size of nine should be enough to verify the supposed sufficient seal in FFP2 described by Ciotti et al.11 (18.3%) and a presumed success rate of 80% with ADR considering a power = 0.8 with a significance level of 0.05. Sex as a biological variable Participants confirmed not to have smoked in the hour before testing and males were clean shaven within 12 hours. Table 2: Resources
Software and Algorithms Sentences Resources The principle of the PortaCount is based on a condensation particle counter. PortaCountsuggested: NoneResults 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: We detected the following sentences addressing limitations in the study:The study has limitations that need to be acknowledged. The study methodology was designed to approximate EN-149 European standardization protocols that certify FFP2 respirators, which only need 10 respirators to be tested.5 However, the sample size of 10 subjects is small for any statistical interpretation and also represents only a limited variety of facial morphologies. We did not take face measures but included participants of both sexes equally to enforce a certain variety in facial morphologies. As stated in the PortaCount manual, it should be clarified that the measurement provided by the PortaCount is an assessment of respirator fit during the fit test only. Respirator fit at other times will vary. The fit factor value is not intended for use in calculating an individual’s actual exposure to hazardous substances.10 This study does not fulfil any certification norms and should not be considered as an approval to use noncertified PPE. Extrapolating the results presented in this study to other individuals or materials than those tested is up to the reader’s discretion. Certified and ideally preliminary face fitted respiratory PPE should always be used when available. Proof of airtightness alone is no proof of real-life protection from hazardous aerosols. We surveyed for several subjective comfort evaluations, but participants wore the different respirators only for several minutes which does not reflect a realistic wearing duration. However, the current state of emergenc...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04375774 Recruiting Verification of Alternative Do-it-yourself Equipment Respira… 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:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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