NCT04681365

Evaluating Bubble-PAPR for Healthcare Workers

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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.

Conditions

• Covid19

Interventions

Type	Name	Description
OTHER	Staff 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)

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-12-23
• Completion: 2021-12-31
• First posted: 2020-12-23
• Last updated: 2022-01-20

Locations

1 site across 1 country: United Kingdom