Covid19BubblePAPRNCT04681365
Evaluating Bubble-PAPR for Healthcare Workers
An observational study of Covid19, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Provision of informed consent; bedside clinical staff (medical, nursing, allied healthcare professional) who manage patients with COVID-19 disease during routine clinical duties.
Who cannot join
- Refusal to participate; unable to, or unwilling to wear the Bubble PAPR
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WU
About this study
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)
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).
Read the 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.
- Conditions
- Covid19
- Being tested
- Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR) | |
| 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). Receives: Other: Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR) | |
| 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). Receives: Other: Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1month
Secondary outcomes (3)
Staff rate Bubble PAPR as safer than current PPE
Measured: 1month
Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE
Measured: 1month
Staff rate Bubble PAPR as easier to communicate with patients than existing PPE
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start24 Feb 2021
- Primary completion23 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681365
- Sponsor's protocol ID
- B00991
- Acronym
- BubblePAPR
- Status last verified
- Jan 2022
- First submitted
- 18 Dec 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGrath BA, Shelton CL, Gardner A, Coleman R, Lynch J, Alexander PG, Cooper G. Bubble-PAPR: a phase 1 clinical evaluation of the comfort and perception of a prototype powered air-purifying respirator for use by healthcare workers in an acute hospital setting. BMJ Open. 2023 May 8;13(5):e066524. doi: 10.1136/bmjopen-2022-066524.
PubMed 37156585
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04681365
- Acronym / sponsor ID
- BubblePAPR / B00991
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simulation Suite | – | Other: 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 | – | Other: 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 | – | Other: 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Provision of informed consent; bedside clinical staff (medical, nursing, allied healthcare professional) who manage patients with COVID-19 disease during routine clinical duties.
Key exclusion criteria (1 listed)
- Refusal to participate; unable to, or unwilling to wear the Bubble PAPR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | High-Risk Clinical Environment, Low-Risk Clinical Environment, Simulation Suite |
Primary outcome
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).
3 secondary outcomes
Staff rate Bubble PAPR as safer than current PPE
Time frame: 1month
Staff rate Bubble PAPR as easier to communicate with colleagues than existing PPE
Time frame: 1month
Staff rate Bubble PAPR as easier to communicate with patients than existing PPE
Time frame: 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Derived from this study: PubMed 37156585McGrath BA, Shelton CL, Gardner A, Coleman R, Lynch J, Alexander PG, Cooper G. Bubble-PAPR: a phase 1 clinical evaluation of the comfort and perception of a prototype powered air-purifying respirator for use by healthcare workers in an acute hospital setting. BMJ Open. 2023 May 8;13(5):e066524. doi: 10.1136/bmjopen-2022-066524.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is that participating staff rate Bubble PAPR to be more comfortable than current PPE. (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04681365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.