Verification of Alternative Do-it-yourself Equipment Respirators for the COVID-19 Personal Protective Equipment (PPE) (VADER)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: COVID

Treatments: Device: Facial mask; Device: FFP2; Device: MFS

Study type: Interventional

Funder types: Other

Identifiers

NCT04375774

2020/15AVR/226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

FFP2

Other group

Treatment:

Device: FFP2

Facial mask

Other group

Treatment:

Device: Facial mask

Modified full-face snorkeling

Other group

Treatment:

Device: MFS