Evaluating Bubble-PAPR for Healthcare Workers

Covid19 Clinical Trial

— BubblePAPR  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681365
• Other study ID #: B00991
• Status: Completed
• Start date: February 24, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 31, 2021
• Est. primary completion date: December 23, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Staff rate Bubble PAPR as safer than current PPE		1month
Secondary	Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE		1month
Secondary	Staff rate Bubble PAPR as easier to communicate with patients than existing PPE		1month

External Links

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