Clinical trial NCT04681365: Evaluating Bubble-PAPR for Healthcare Workers
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
First posted: 2020-12-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE.
timeFrame: 1month
Secondary outcomes:
measure: Staff rate Bubble PAPR as safer than current PPE
timeFrame: 1month
measure: Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE
timeFrame: 1month
measure: Staff rate Bubble PAPR as easier to communicate with patients than existing PPE
timeFrame: 1month
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References: