Covid19 Clinical Trial - Evaluating Bubble-PAPR for Healthcare Workers

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04681365
Study type	Observational
Source	Manchester University NHS Foundation Trust
Contact
Status	Completed
Phase
Start date	February 24, 2021
Completion date	December 31, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating Bubble-PAPR for Healthcare Workers — BubblePAPR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms