None listed
Conditions
Brief summary
COVID-19 is a major global pandemic. A current major issue in countries dealing with COVID-19 is the availability of safe and effective masks for health care workers. The current recommended gold standard mask is the P2/N95 mask for health care workers in high exposure environments. Unfortunately, for many health care workers, there continues to be residual peri-mask leak with existing off-the-shelf standard mask designs. In this project, we develop customized 3D-printed facial shields that could be worn by health care workers as a supplementary barrier to prevent peri-mask leak.
Interventions
The project will involve the evaluation of 3D-printed facial guards on N95 face mask leak. Participants in the study will have a face scan with a mobile phone app, that acquires a 3D topographic geometry of the face. Using this scan, a customised face guard is 3D-printed by our engineering team. Following fitting, each participant will have Portacount quantitative fit testing performed by a resarch fellow or nurse, with an N95 worn in the standard fashion, and with the 3D-printed face guard in c
The project will involve the evaluation of 3D-printed facial guards on N95 face mask leak. Participants in the study will have a face scan with a mobile phone app, that acquires a 3D topographic geometry of the face. Using this scan, a customised face guard is 3D-printed by our engineering team. Following fitting, each participant will have Portacount quantitative fit testing performed by a resarch fellow or nurse, with an N95 worn in the standard fashion, and with the 3D-printed face guard in combination with an N95. Purposeful randomised sampling of the SALHN WHS database will be performed to select n=85 participants who have previously failed quantitative N95 fit testing (who will become the interventional group receiving a 3D-printed facial guard plus P2/N95). Each participant will have approximately 15 minute taken with a scanning visit, and then a 30-45 minute second visit for testing.
Sponsors
Flinders University
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Any health care worker or SA Health employee who has undergone quantitative fit testing. Purposeful randomised sampling of the SALHN WHS database will be performed to select n=85 participants who have previously failed quantitative N95 fit testing (who will become the interventional group receiving a 3D-printed facial guard plus P2/N95). A second group of n=85 participants who have previously passed quantitative fit tests will be selected for re-testing with P2/N95 masks as a control group, to ensure that a contemporaneous control group is analysed under the same conditions as the interventional group.
Exclusion criteria
Are based on current exclusions from SA Health fit testing guidelines: (i) Active asthma or respiratory condition requiring treatment may be a relative contraindication to fit testing; (ii) Pregnancy; (iii) Active upper respiratory tract infection, fever, or other suspected infection.
Outcome results
None listed