Article Text

Original research
Bubble-PAPR: a phase 1 clinical evaluation of the comfort and perception of a prototype powered air-purifying respirator for use by healthcare workers in an acute hospital setting
  1. Brendan A McGrath1,2,
  2. Clifford L Shelton3,4,
  3. Angela Gardner1,
  4. Ruth Coleman1,
  5. James Lynch1,
  6. Peter G Alexander1,2,
  7. Glen Cooper5
  1. 1Acute Intensive Care Unit, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK
  2. 2Manchester Academic Critical Care, Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Science Centre, Manchester, UK
  3. 3Department of Anaesthesia, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK
  4. 4Lancaster Medical School, Lancaster University, Lancaster, UK
  5. 5The University of Manchester School of Mechanical Aerospace and Civil Engineering, Manchester, UK
  1. Correspondence to Dr Brendan A McGrath; brendan.mcgrath{at}manchester.ac.uk

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 filtering face piece (FFP3) face mask respiratory protective equipment (RPE) in the domains of comfort, perceived safety and communication.

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 covering materials; inward particulate leakage; breathing resistance; clean air filtration and supply; carbon dioxide elimination; exhalation means and electrical safety. Questionnaire-based usability data from participating front-line 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 National Health Service 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 min (IQR 30–80 (15–120)). Participants self-reported a range of heights (mean 1.7 m (SD 0.1, range 1.5–2.0)), weights (72.4 kg (16.0, 47–127)) and body mass indices (25.3 (4.7, 16.7–42.9)).

Outcome measures Preuse particulometer ‘fit testing’ and evaluation against standards by an independent biomedical engineer.

Primary:Perceived comfort (Likert scale).

Secondary: Perceived safety, communication.

Results Mean fit factor 16 961 (10 participants). Bubble-PAPR mean comfort score 5.64 (SD 1.55) vs usual FFP3 2.96 (1.44) (mean difference 2.68 (95% CI 2.23 to 3.14, p<0.001). Secondary outcomes, Bubble-PAPR mean (SD) versus FFP3 mean (SD), (mean difference (95% CI)) were: how safe do you feel? 6.2 (0.9) vs 5.4 (1.0), (0.73 (0.45 to 0.99)); speaking to other staff 7.5 (2.4) vs 5.1 (2.4), (2.38 (1.66 to 3.11)); heard by other staff 7.1 (2.3) vs 4.9 (2.3), (2.16 (1.45 to 2.88)); speaking to patients 7.8 (2.1) vs 4.8 (2.4), (2.99 (2.36 to 3.62)); heard by patients 7.4 (2.4) vs 4.7 (2.5), (2.7 (1.97 to 3.43)); all p<0.01.

Conclusions Bubble-PAPR achieved its primary purpose of keeping staff safe from airborne particulate material while improving comfort and the user experience when compared with usual FFP3 masks. The design and development of Bubble-PAPR were conducted using a careful evaluation strategy addressing key regulatory and safety steps.

Trial registration number NCT04681365.

  • OCCUPATIONAL & INDUSTRIAL MEDICINE
  • INTENSIVE & CRITICAL CARE
  • Infection control
  • ANAESTHETICS
  • RESPIRATORY MEDICINE (see Thoracic Medicine)

Data availability statement

Data are available on reasonable request. Due to the commercial sensitivity of the intellectual property licensed at the conclusion of this project, the full dataset is not publicly available. However, the corresponding author will consider requests to disclose the dataset on an individual basis if necessary.

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Data availability statement

Data are available on reasonable request. Due to the commercial sensitivity of the intellectual property licensed at the conclusion of this project, the full dataset is not publicly available. However, the corresponding author will consider requests to disclose the dataset on an individual basis if necessary.

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Footnotes

  • Twitter @BrendanAMcGrath, @DrCliffShelton

  • Contributors All authors critically revised the manuscript for important intellectual content and approved the final manuscript. BAM attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. BAM acts as guarantor. BAM: conception and design, collection, analysis and interpretation of data, drafting and revision of the manuscript, and final approval of the version to be published. Participant recruitment. CLS: qualitative work package conception and design, analysis and interpretation of data, participant recruitment, drafting and revision of the final manuscript, and final approval of the version to be published. AG: qualitative work package design, analysis and interpretation of data. Drafting and revision of the final manuscript, and final approval of the version to be published. RC: design, collection and interpretation of data, drafting and revision of the manuscript, and final approval of the version to be published. JL: design, collection and interpretation of data, drafting and revision of the manuscript, and final approval of the version to be published. PGA: design, collection and interpretation of data, drafting and revision of the manuscript, and final approval of the version to be published. GC: design, collection, and interpretation of data, drafting and revision of the manuscript, and final approval of the version to be published, manufacturing and engineering lead.

  • Funding This project was supported by unrestricted grants and funding from Engineering and Physical Sciences Research Council (EPSRC) Impact Acceleration Account 302, Oxford Road Corridor (grant award number N/A), Health Innovation Manchester ‘Momentum’ special projects fund 2021 (grant award number N/A), Acute ICU Charitable Research Fund, Manchester University NHS Foundation Trust (grant award number N/A) and Manchester University NHS Foundation Trust (grant award number N/A).

  • Competing interests Manchester University NHS Foundation Trust, the University of Manchester and Designing Science Ltd have agreed commercial terms to license Bubble-PAPR for manufacture and development. No other competing interests are declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.