Evaluating Bubble-PAPR for Healthcare Workers (BubblePAPR)

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)

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).

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WU
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state otherwise.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Simulation Suite; 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	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)
Low-Risk Clinical Environment; 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).	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)
High-Risk Clinical Environment; 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).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE.	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).	1month

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: University of Manchester

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: B00991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No