ArticleBMJ open2023
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.
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04681365 (A Phase I Study of an 'In-house' Developed Prototype Powered Air Purifying Respirator), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Study of an 'In-house' Developed Prototype Powered Air Purifying Respirator (PAPR) for Use as Personal Protective Equipment (PPE) for Healthcare Workers (Bubble PAPR)
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- The carbon footprint of Bubble-PAPR™: A novel item of personal protective equipment.Journal of the Intensive Care Society · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 MEASURES: Preuse 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 NUMBER: NCT04681365.
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