Results
SECONDARY, PVC, RECRUITMENT
The final design of Bubble-PAPR is shown schematically in Bubble-PAPR comprises a medical-grade foam neck collar and a separate polyvinyl chloride (PVC) hood. The universal fit collar draws air in through a filter via an impeller powered by an external battery. The collar has a mechanical low flow indicator and can be cleaned and reused by different users. The semirigid hood is pulled over the collar before donning and is secured by integrated straps. PAPR, National Health Service.Fifteen staff contributed to the diary and focus group exercises. Nurses (n=7), doctors (4), physiotherapists (2), advanced practitioners (1), speech and language therapists (1) representing emergency medicine, critical care, orthopaedics and obstetric specialties generated a list of tasks to be undertaken. One staff member from the 16 invited could not attend the focus group meeting. Staff reported a range of patient-facing activities, including: verbal communication between colleagues and patients; writing; typing; reading notes, computer screens and monitors; manual handling; invasive procedures; emergency resuscitation; airway management; and maintenance of a clean/safe bedside environment. Over the course of the evaluation, staff completed all of the tasks identified by the diary exercise while wearing Bubble-PAPR in the clinical environment. Ninety-one staff wore Bubble-PAPR for a median of 45 (IQR 30–90, range 10–150) min between 3 March 2021 and 21 December 2021. All relevant staff working in relevant clinical areas were approached until a maximum of six staff had been recruited per shift (the most that the research team could reasonably accommodate per shift), or the recruitment target had been met. No staff who were approached during their clinical shifts were unwilling or unable to trial Bubble-PAPR. There were no Bubble-PAPR-related safety incidents reported during the study. Staff undertook all clinical duties identified by the focus groups and diary card exercise, either in the simulation suite (n=22) or clinical settings (n=22 low risk, n=25 high risk, n=22 high risk with final iteration). Participants predominantly declared as female (69%) and were from a range of clinical and non-clinical roles (
Reported comfort (primary) and safety (secondary) outcomes for Bubble-PAPR versus usual FFP3 face masks. FFP, filtering face piece; PAPR, powered air-purifying respirator; PPE, personal protective equipment.With pooled data for the primary outcome, ‘How comfortable do you feel in your PPE?’ (Likert scale bounded by 1 (very uncomfortable) to 7 (very comfortable)), Bubble-PAPR mean score was 5.64 (SD 1.55) vs usual FFP3 face mask 2.96 (1.44; Secondary communication outcomes where a higher Likert scale response was considered better. FFP, filtering face piece; PPE, personal protective equipment.Rating scales, summary results and comparisons across the primary outcome questionnaire domainsFFP, filtering face piece; RPE, respiratory protective equipment.Secondary outcomes where a lower Likert response was considered better are presented in During the initial phases, there was no significant difference between staff reporting ease of donning and doffing of Bubble-PAPR and usual PPE (the FFP3 face masks which staff had used for many months at the time of the evaluation). However, pooled results saw staff becoming more familiar with the Bubble, and Bubble-PAPR was rated easier to don and doff when compared with usual FFP3 face masks (adjusted p=0.003 and 0.002, respectively) (