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NCT05143814
3D Printed Mask Adapter Designed From Facial 3D Scans for Fit Testing.
trial testing 3D Printed Mask Adapter Designed from Facial 3D scans for Fit testing. in COVID-19 Pandemic. Withdrawn.
31 January 2024
Quick facts
| Lead sponsor | Barts & The London NHS Trust |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 August 2023 |
| Primary completion | 31 January 2024 |
| Estimated completion | 25 February 2024 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- 3D Printed Mask Adapter Designed from Facial 3D scans for Fit testing.
Conditions studied
- COVID-19 Pandemic — all drugs for COVID-19 Pandemic →
Sponsor
Barts & The London NHS Trust — full company profile →
Who can join
18 and older, any sex, with COVID-19 Pandemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05143814
- Europe PMC full search
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Other Barts & The London NHS Trust trials
Trials by the same sponsor.
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- NCT06596486 — A Comparison of CoolStick With Ethyl Chloride for the Assessment of Light Touch · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05143814 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Barts & The London NHS Trust
- Last refreshed: 23 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05143814.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing