COVID-19 PandemicNCT05143814
3D Printed Mask Adapter Designed From Facial 3D Scans for Fit Testing.
An observational study of COVID-19 Pandemic, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Healthcare workers PPE (personal protective equipment) when interacting with patients either infected or, potentially carrying SARS-CoV-2. One of the major routes of transmission is via droplet spread through oral and nasal mucosa therefore respiratory protective equipment (RPE) is an important part of PPE. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- 3D Printed Mask Adapter Designed from Facial 3D scans for Fit testing.
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to 25 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare staff in Barts Healthy NHS trust who meet the inclusion criteria.
Who may be able to join
- Subjects who would have previously failed the quantitative fit test on the Trust's first line FFP3 disposable respirator.
- Subjects willing to use a flexible, disposable FFP3 mask.
- Subjects should be a minimum of 18 years old.
Who cannot join
- Subjects unwilling or unable to give written consent.
- Subjects who cannot remove their facial hair for religious or other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study Investigating the Success Rate of Fit Testing Following the Use of a 3D Printed Respirator Adapter From a Facial 3D Scan.
Healthcare workers PPE (personal protective equipment) when interacting with patients either infected or, potentially carrying SARS-CoV-2. One of the major routes of transmission is via droplet spread through oral and nasal mucosa therefore respiratory protective equipment (RPE) is an important part of PPE. There are concerns in dentistry that droplet spread can be increased during aerosol-generating procedures (AGP). This poses an increased risk to dentists and allied professionals in a clinical setting.
Fit testing is needed to ensure a mask forms a facial seal around the mouth and nose. Using a respirator mask without fit testing can reduce its effectiveness from between 6-88% with an optimal facial seal being more critical than the filtering performance. Commercial respirator masks are mass-produced for ' standard' faces, and often fail to provide a good fit for users thereby compromising the intended respirator filtering capability.
Read more
Given the high level of fit test failures, without the provision of improved fits of masks, patient care will be highly curtailed for frontline staff at risk of SARS-CoV-2. Therefore, a reusable bespoke 3D printed mask adapter used with a soft FFP3 disposable mask provides an economical solution to address the passing of fit testing.
Barts Health NHS Trust staff members who have previously failed the fit test to the first line FFP3 disposable respirator will be invited to enrol in this study.
Barts/QMUL scan App will be used to capture the facial scan of the subjects using a research allocated smartphone. Participants will be asked to be clean-shaven without any facial jewellery which could hinder the scan data. The App automatically generates a customized 3D print file (.stl) which will be sent for 3D printing.
The mask adapter will be fitted over the first-line FFP3 respirator once it is properly worn and checked as per the procedure.
- Conditions
- COVID-19 Pandemic
- Being tested
- 3D Printed Mask Adapter Designed from Facial 3D scans for Fit testing.
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Mask Adapter Designed from Facial 3D scans for Fit testing.Device
Given the high level of fit test failures, without the provision of improved fits of masks, patient care will be highly curtailed for frontline staff at risk of SARS-CoV-2. Therefore, a reusable bespoke mask adapter used with a soft FFP3 disposable mask might be an economical solution to address the passing of fit testing. Currently, this is a major challenge in delivery of healthcare and urgent action is needed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of of fit testing will be measured and reported quantitively using a TSI portacount
Measured: 20 minutes mask fit test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Aug 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion25 Feb 2024 (estimated)
Why it stopped: COVID-19 suspension non-urgent studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143814
- Sponsor's protocol ID
- 289974
- Status last verified
- Aug 2024
- First submitted
- 23 Nov 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Investigating the Success Rate of Fit Testing Following the Use of a 3D Printed Respirator Adapter From a Facial 3D Scan.
- ClinicalTrials.gov ID
- NCT05143814
- Acronym / sponsor ID
- 289974
- Conditions
- COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19 suspension non-urgent studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 25 Feb 2024 (estimated)
- First posted
- 3 Dec 2021 (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.
Healthcare workers PPE (personal protective equipment) when interacting with patients either infected or, potentially carrying SARS-CoV-2. One of the major routes of transmission is via droplet spread through oral and nasal mucosa therefore respiratory protective equipment (RPE) is an important part of PPE. There are concerns in dentistry that droplet spread can be increased during aerosol-generating procedures (AGP). This poses an increased risk to dentists and allied professionals in a clinical setting.
Fit testing is needed to ensure a mask forms a facial seal around the mouth and nose. Using a respirator mask without fit testing can reduce its effectiveness from between 6-88% with an optimal facial seal being more critical than the filtering performance. Commercial respirator masks are mass-produced for ' standard' faces, and often fail to provide a good fit for users thereby compromising the intended respirator filtering capability.
Given the high level of fit test failures, without the provision of improved fits of masks, patient care will be highly curtailed for frontline staff at risk of SARS-CoV-2. Therefore, a reusable bespoke 3D printed mask adapter used with a soft FFP3 disposable mask provides an economical solution to address the passing of fit testing.
Barts Health NHS Trust staff members who have previously failed the fit test to the first line FFP3 disposable respirator will be invited to enrol in this study.
Barts/QMUL scan App will be used to capture the facial scan of the subjects using a research allocated smartphone. Participants will be asked to be clean-shaven without any facial jewellery which could hinder the scan data. The App automatically generates a customized 3D print file (.stl) which will be sent for 3D printing.
The mask adapter will be fitted over the first-line FFP3 respirator once it is properly worn and checked as per the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare staff in Barts Healthy NHS trust who meet the inclusion criteria.
Key inclusion criteria (3 listed)
- Subjects who would have previously failed the quantitative fit test on the Trust's first line FFP3 disposable respirator.
- Subjects willing to use a flexible, disposable FFP3 mask.
- Subjects should be a minimum of 18 years old.
Key exclusion criteria (2 listed)
- Subjects unwilling or unable to give written consent.
- Subjects who cannot remove their facial hair for religious or other reasons.
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 |
|---|---|---|
| 3D Printed Mask Adapter Designed from Facial 3D scans for Fit testing.Given the high level of fit test failures, without the provision of improved fits of masks, patient care will be highly curtailed for frontline staff at risk of SARS-CoV-2. Therefore, a reusable bespoke mask adapter used with a soft FFP3 disposable mask might be an economical solution to address the passing of fit testing. Currently, this is a major challenge in delivery of healthcare and urgent action is needed. | Device | – |
Primary outcome
The success of of fit testing will be measured and reported quantitively using a TSI portacount
Time frame: 20 minutes mask fit test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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 COVID-19 Pandemic, run by Barts & The London NHS 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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 success of of fit testing will be measured and reported quantitively using a TSI portacount (time frame: 20 minutes mask fit test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2024.