Evaluating Bubble-PAPR for Healthcare Workers

Completed

• Conditions: Covid19
• Interventions: Other: Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)

• Registration Number: NCT04681365
• Lead Sponsor: Manchester University NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-02-24
• Primary Completion: 2021-12-23
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simulation Suite	Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)	Participating staff will use BubblePAPR and evaluate its function in the non-clinical simulation suite, ensuring that simulated tasks appropriate to role can be undertaken safely whilst wearing the Bubble
Low-Risk Clinical Environment	Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)	Participating staff will use BubblePAPR and evaluate its function in the usual clinical environments (wards, ICUs or Emergency Departments) but with patients who are considered low risk (ie non-COVID-19).
High-Risk Clinical Environment	Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)	Participating staff will use BubblePAPR and evaluate its function in the usual clinical environments (wards, ICUs or Emergency Departments) but with patients who are considered high risk (ie suspected or confirmed COVID-19).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE	1month
Staff rate Bubble PAPR as safer than current PPE	1month
Staff rate Bubble PAPR as easier to communicate with patients than existing PPE	1month

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom