Bubble-PAPR: Phase I clinical evaluation of an in-house developed prototype powered air-purifying respirator for use by healthcare workers

Abstract

Objectives: We aimed to design and produce a low-cost, ergonomic, hood-integrated Powered Air-Purifying Respirator (Bubble-PAPR) for pandemic healthcare use, offering optimal and equitable protection to all staff. We hypothesised that participants would rate Bubble-PAPR more highly than current FFP3 face mask respiratory protective equipment (RPE). Design: Rapid design and evaluation cycles occurred based on the identified user needs. We conducted diary card and focus group exercises to identify relevant tasks requiring RPE. Lab-based safety standards established against British Standard BS-EN-12941 and EU2016/425. Questionnaire-based usability data from participating frontline healthcare staff before (usual RPE) and after using Bubble-PAPR. Setting: Overseen by a trial safety committee, evaluation progressed sequentially through laboratory, simulated, low-risk, then high-risk clinical environments of a single tertiary NHS hospital. Participants: 15 staff completed diary cards and focus groups. 91 staff from a range of clinical and non-clinical roles completed the study, wearing Bubble-PAPR for a median of 45 minutes (IQR 30-80 [15-120]). Participants self-reported a range of heights (mean 1.7m [SD 0.1, range 1.5-2.0]), weights (72.4kg [16.0, 47-127]) and body mass indices (25.3 [4.7,16.7-42.9]). Outcome measures: Primary: How comfortable do you feel in your PPE? (Likert scale bounded by 1 [very uncomfortable] to 7 [very comfortable]). Secondary outcomes: perceived safety, communication, anxiety, discomfort, and performance. Results: Bubble-PAPR mean comfort score was 5.64(SD 1.55) versus usual FFP3 2.96(1.44) (mean difference 2.68 (95% CI 2.23-3.14, p<0.001). There was a significant difference in favour of Bubble-PAPR across all secondary outcomes. Conclusions: Bubble-PAPR achieved its primary purpose of keeping staff safe from airborne particulate material whilst improving comfort and the user experience. The design and development of Bubble-PAPR were conducted using a careful evaluation strategy addressing key regulatory and safety steps, in contrast to many devices rapidly developed and deployed during the pandemic. Trial registration: IRAS ID:288493, REC Ref:21/WA/0018. ClinicalTrials.gov (NCT04681365).

Competing Interest Statement

Manchester University NHS Foundation Trust, the University of Manchester and Designing Science Ltd have agreed commercial terms to license an updated, re-branded Bubble-PAPR with a UK Healthcare manufacturer. The collaboration may benefit financially from future sales.

Clinical Trial

NCT04681365

Funding Statement

This project was supported by unrestricted grants and funding from Engineering and Physical Sciences Research Council (EPSRC) Impact Acceleration Account 302 Oxford Road Corridor (no relevant grant award number) Health Innovation Manchester Momentum special projects fund 2021 Acute ICU Charitable Research Fund, Manchester University NHS Foundation Trust (no relevant grant award number) Manchester University NHS Foundation Trust (no relevant grant award number)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics Committee Wales REC-5 gave ethical approval for this work. Research Ethical and Health Research Authority approval (IRAS ID:288493, REC Ref:21/WA/0018). Manchester University NHS Foundation Trust sponsored the study, acting as the manufacturer of this in-house prototype device. The study protocol, analysis plan and recruitment metrics were registered and reported at ClinicalTrials.gov (NCT04681365).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

The full dataset is potentially commercially sensitive. However, all data produced in the present study are available upon reasonable request to the authors

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