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Completed

NCT Number: NCT04681365

Evaluating Bubble-PAPR for Healthcare Workers

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).

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)

Other

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)

Primary outcomes

  1. The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE.

    Time frame: 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 outcomes

  1. Staff rate Bubble PAPR as safer than current PPE

    Time frame: 1month

  2. Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE

    Time frame: 1month

  3. Staff rate Bubble PAPR as easier to communicate with patients than existing PPE

    Time frame: 1month

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • University of Manchester

Registry information

Official study 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)

Acronym: BubblePAPR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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