TY - JOUR

T1 - Bubble-PAPR

T2 - 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

AU - McGrath, Brendan A

AU - Shelton, Clifford L

AU - Gardner, Angela

AU - Coleman, Ruth

AU - Lynch, James

AU - Alexander, Peter G

AU - Cooper, Glen

PY - 2023/5/8

Y1 - 2023/5/8

N2 - ObjectivesWe 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.DesignRapid 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.SettingOverseen 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.Participants15 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 measuresPreuse particulometer ‘fit testing’ and evaluation against standards by an independent biomedical engineer.Primary:Perceived comfort (Likert scale).Secondary: Perceived safety, communication.ResultsMean 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.ConclusionsBubble-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 numberNCT04681365.

AB - ObjectivesWe 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.DesignRapid 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.SettingOverseen 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.Participants15 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 measuresPreuse particulometer ‘fit testing’ and evaluation against standards by an independent biomedical engineer.Primary:Perceived comfort (Likert scale).Secondary: Perceived safety, communication.ResultsMean 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.ConclusionsBubble-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 numberNCT04681365.

KW - General Medicine

U2 - 10.1136/bmjopen-2022-066524

DO - 10.1136/bmjopen-2022-066524

M3 - Journal article

C2 - 37156585

VL - 13

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 5

M1 - e066524

ER -