Outcomes
anxiety
The primary outcome was based on Davis’ technology acceptance model (perceived usefulness and perceived ease-of-use overcoming barriers to adoption).The primary endpoint was staff rating of the comfort of Bubble-PAPR (vs current FFP3 face masks). Secondary endpoints focused on communication and perceived safety. Specifically, this was staff ratings of the prototype in terms of: how safe participants felt, ease of communication with colleagues and ease of communication with patients (again, Bubble-PAPR vs current FFP3 face masks). Additional questions explored wearer anxiety, ease of use and performance while undertaking usual work tasks. In parallel, in-house device feasibility testing was conducted in the hospital environment to test ergonomics and air particle filtration. The research framework for this study was based around in-house exemption for device development from the UK Medicines and Healthcare products Regulatory Agency. This means that the hospital, acting as manufacturer, can use a device it has developed itself internally. Such a device is not required to undergo to independent testing and therefore it will not achieve a certificate of conformity (UK-Conformity Assessed or Conformitè Europëenne marking). However, in order to assure the study sponsor and staff participants of the safety and efficacy of Bubble-PAPR, we tested against existing conformity standards for PAPRs relevant at the time of development (British Standard BS EN 12941 (Respiratory Protective Devices: Powered filtering devices incorporating a helmet or hood) and the European Union Personal Protective Equipment Directive EU2016/425).