Investigating the effect of 3D printed facial guards on leak from P2/N95 respirators

Not Applicable

Recruiting

• Conditions: Face mask fit in health care workers; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622000388718
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-07
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative fit factor on Portacount testing on 3D Face guard +N95 vs standard N95 alone[At time of fit test]

Secondary Outcome Measures

Name	Time	Method
Proportion of health care workers passing quantitative fit test with 3D face guard vs control group[At time of fit test]