Dataset Information

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.

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.

SUBMITTER: McGrath BA

PROVIDER: S-EPMC10174029 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

McGrath Brendan A BA Shelton Clifford L CL Gardner Angela A Coleman Ruth R Lynch James J Alexander Peter G PG Cooper Glen G

BMJ open 20230508 5

<h4>Objectives</h4>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.<h4>Design</h4>Rapid design and evaluation cycles occurred ...[more]

PMID: 37156585

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Project description:BackgroundHealthcare workers (HCWs) are at particular risk during pandemics and epidemics of highly virulent diseases with significant morbidity and case fatality rate. These diseases include severe acute respiratory syndrome coronaviruses, SARS-CoV-1 and SARS-CoV-2, Middle Eastern Respiratory Syndrome (MERS), and Ebola. With the current (SARS-CoV-2) global pandemic, it is critical to delineate appropriate contextual respiratory protection for HCWs. The aim of this systematic review was to evaluate the effect of powered air-purifying respirators (PAPRs) as part of respiratory protection versus another device (egN95/FFP2) on HCW infection rates and contamination.MethodsOur primary outcomes included HCW infection rates with SARS-CoV-2, SARS-CoV-1, Ebola, or MERS when utilizing PAPR. We included randomized controlled trials, non-randomized controlled trials, and observational studies. We searched the following databases: MEDLINE, EMBASE, and Cochrane Library (Cochrane Database of Systematic Reviews and CENTRAL). Two reviewers independently screened all citations, full-text articles, and abstracted data. Due to clinical and methodological heterogeneity, we did not conduct a meta-analysis. Where applicable, we constructed evidence profile (EP) tables for each individual outcome. Confidence in cumulative evidence for each outcome was classified according to the GRADE system.ResultsWe identified 689 studies during literature searches. We included 10 full-text studies. A narrative synthesis was provided. Two on-field studies reported no difference in the rates of healthcare workers performing airway procedures during the care of critical patients with SARS-CoV-2. A single simulation trial reported a lower level of cross-contamination of participants using PAPR compared to alternative respiratory protection. There is moderate quality evidence that PAPR use is associated with greater heat tolerance but lower scores for mobility and communication ability. We identified a trend towards greater self-reported wearer comfort with PAPR technology in low-quality observational simulation studies.ConclusionField observational studies do not indicate a difference in healthcare worker infection utilizing PAPR devices versus other compliant respiratory equipment. Greater heat tolerance accompanied by lower scores of mobility and audibility in PAPR was identified. Further pragmatic studies are needed in order to delineate actual effectiveness and provider satisfaction with PAPR technology.Systematic review registrationThe protocol for this review was prospectively registered with the International Register of Systematic Reviews identification number CRD42020184724 .

Project description:The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.

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Dataset Information

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.

Objectives

Design

Setting

Participants

Outcome measures

Results

Conclusions

Trial registration number

Publications

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.

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