Bubble PAPR
Research type
Research Study
Full title
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)
IRAS ID
288493
Contact name
Brendan McGrath
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
The COVID-19 global pandemic created both a worldwide shortage of personal protective equipment, PPE (WHO, 2020), and highlighted major usability issues in current PPE products (Chartered Institute of Human Factors & Ergonomics, 2020). Disposable PPE is cheap but not designed to be worn for long periods, may restrict vision and communication, requires multiple time-consuming ‘fit tests’ for each brand, and causes facial damage (facial pressure points/lesions); issues also demonstrated in the SARS epidemic (Foo, 2006). Conversely more expensive solutions, eg 3M’s Purified Air Powered Respirator (PAPR) are not designed primarily for healthcare, are heavy, noisy, expensive, difficult to clean to clinical standards and not fit for the specific needs in Intensive Care Unit (ICU) or ward environments.
A collaboration between Manchester University NHS Foundation Trust (the manufacturer, MFT), Designing Science Ltd and the University of Manchester has produced a low cost, ergonomic, hood integrated PAPR for use initially within the NHS. The Bubble PAPR is undergoing testing towards full CE marking, which will take around 3 months. In the interim, we plan an in-house usability evaluation which will ultimately contribute to CE marking and regulatory approval.
Bubble PAPR is classified as Personal Protective Equipment (PPE) and not as a Medical Device.
This application details the in house testing of the Bubble PAPR units against the relevant regulatory clauses and the subsequent user evaluations by frontline healthcare staff at MFT.
REC name
Wales REC 5
REC reference
21/WA/0018
Date of REC Opinion
27 Jan 2021
REC opinion
Favourable Opinion