Official Title
Verification of Alternative Do-it-yourself Equipment Respirators
Brief Summary

The COVID-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . This shortage specifically affects high-quality protective masks, such as those called FFP2. As alternatives, we offer a reusable mask based on a ventilation mask combined with a breathing filter for anesthesia breathing circuits. The purpose of the study is to assess the sealing potential of this mask in the field and possibly prove a non-inferior sealing compared to standard masks type FFP2.

Detailed Description

The ongoing 2020 COVID-19 pandemic challenges healthcare providers (HCP) worldwide with a
rapid consumption and shortage of personal protection equipment (PPE), especially high-level
filtration respirator masks. Respirators used by HCPs are mainly single use face filtering
pieces with at least level P2 protection for single shift use following European EN 149
standards defining protection level against hazardous particles.

In response to the risk of shortage we propose a novel reusable do-it-yourself (DIY)
respirator assembled with already widely available components in hospital stocks: a standard
breathing filter plugged in an anaesthesia facial mask held in place with a hook ring
strapped to a silicone head harness. As reports of a modified full-face snorkelling (MFS)
mask used for non-invasive ventilation in infected patients emerged in Italy, we reckon that
it could also be used as PPE with a modified valve and breathing filter.

Unknown status
COVID

Device: FFP2

Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI

Device: Facial mask

Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI

Device: MFS

Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI

Eligibility Criteria

Inclusion Criteria:

- adult volunteers working in a first line healthcare service with basic knowledge of
donning PPE including respirators

- 5 females and 5 males

Exclusion Criteria:

- smoking or unhealthy participants with respiratory affections to avoid breathing
difficulties during testing

- any known allergy towards medical silicone or any other material of each component and
ingredients used for disinfection of the test area and material between participants

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Belgium
Locations

Cliniques Universitaires Saint-Luc
Brussels, Belgium

Investigator: Guillaume Lemaire, MD
Contact: +322764-1870
guillaume.lemaire@uclouvain.be

Contacts

Guillaume Lemaire, MD
+3227641870
guillaume.lemaire@uclouvain.be

Marco Pettinger, MD
00352 661 90 20 39
marco@msg.lu

Guillaume Lemaire, MD, Principal Investigator
Cliniques universitaires Saint-Luc

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
NCT Number
Keywords
Covid
protection equipment
3d printable valve
fit test