Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFP2 | Other |
| |
| Facial mask | Other |
| |
| Modified full-face snorkeling | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFP2 | Device | Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of airtightness (Fit test) | Non inferiority claim over FFP2 | Up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| User Comfort | User face comfort for each type of mask assessed by a assessed by a scoring-cale from 1 to 5 | Up to 1 week |
| Breathing easiness | User respiratory easiness for each type of mask assessed by a scoring-cale from 1 to 5 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Lemaire, MD | Contact | +3227641870 | guillaume.lemaire@uclouvain.be | |
| Marco Pettinger, MD | Contact | 00352 661 90 20 39 | marco@msg.lu |
| Name | Affiliation | Role |
|---|---|---|
| Guillaume Lemaire, MD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
All data will be presented in the future manuscript
Not provided
Not provided
Not provided
Not provided
Not provided
Enrolment will be a onetime selection of 10 healthy volunteers
Not provided
Not provided
Not provided
Not provided
| Facial mask |
| Device |
Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI |
|
| MFS | Device | Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI |
|
| Up to 1 week |
| Field of view quality | User field of view quality for each type of mask assessed by a scoring-cale from 1 to 5 | Up to 1 week |
| Ease of use | How the device is user friendly, assessed by a scoring-cale from 1 to 5 | Up to 1 week |