Covid19
Conditions
Brief summary
This project will produce a low cost, ergonomic, hood integrated PAPR for use initially within the NHS. It will focus on user centred design, engineering optimisation, feasibility testing, certification and intellectual property protection. This study will evaluate the pre-CE marked Bubble PAPR prototype PPE in the clinical environment and gather usability data from consenting participants (staff).
Detailed description
Aim: To develop low cost, ergonomic, personal protective equipment to prevent virus transmission to NHS healthcare workers. This project aims to address these problems by taking a user centred design approach to develop and manufacture a highly functional Hood Integrated Personal Air Purifying Respirator (HI-PAPR) at a low cost. The design team brings together Manchester University NHS Foundation Trust (MFT) ICU frontline clinical staff, an experienced product design consultancy, Designing Science Limited (DSL) and the technical expertise of the School of Engineering at the University of Manchester (UoM). The project will run through a rapid design and evaluation cycle in simulated and clinical environments to refine the concept to meet regulatory requirements. The final product could be used in primary/secondary care and in the community and will be ready for wide-scale manufacture and supply for the UK NHS within six months of the project start. This study will evaluate Bubble PAPR in the clinical environment and gather usability data from frontline healthcare staff. We hypothesise that: * The Bubble PAPR will meet or exceed the British and European standards for PAPRs. * That participating staff who subsequently use the PAPR will rate the PPE as: * More comfortable than current PPE * Safer than current PPE * Easier to communicate with colleagues than current PPE * Easier to communicate with patients than current PPE Our research question is: • Do clinical staff report that the Bubble PAPR is more comfortable than current FFP3 facemasks.
Interventions
OTHERStaff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)
Staff will wear and evaluate the Bubble PAPR instead of usual PPE consisting of FFP3/N95 facemasks. This novel, non-CE marked prototype PPE is a Powered air Purifying Respirator and is used 'in house' (not approved for use outside of the Sponsor organisation)
Sponsors
University of Manchester
Manchester University NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
Provision of informed consent; bedside clinical staff (medical, nursing, allied healthcare professional) who manage patients with COVID-19 disease during routine clinical duties.
Exclusion criteria
Refusal to participate; unable to, or unwilling to wear the Bubble PAPR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE. | 1month | Primary outcome measure is 'Comfort' as defined by Q17 of the questionnaire (Please indicate how comfortable the Bubble PAPR is) on a 7-point Likert scale bounded by 1 (very uncomfortable) through to 7 (very comfortable). |
Secondary
| Measure | Time frame |
|---|---|
| Staff rate Bubble PAPR as safer than current PPE | 1month |
| Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE | 1month |
| Staff rate Bubble PAPR as easier to communicate with patients than existing PPE | 1month |
Countries
United Kingdom
Outcome results
None listed