Clinical trial NCT04375774: Verification of Alternative Do-it-yourself Equipment Respirators for the COVID-19 Personal Protective Equipment (PPE)
Official title: Verification of Alternative Do-it-yourself Equipment Respirators
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID
Keywords: COVID
protection equipment
3d printable valve
fit test
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Enrolment will be a onetime selection of 10 healthy volunteers
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Evaluation of airtightness (Fit test)
timeFrame: Up to 1 week
Secondary outcomes:
measure: User Comfort
timeFrame: Up to 1 week
measure: Breathing easiness
timeFrame: Up to 1 week
measure: Field of view quality
timeFrame: Up to 1 week
measure: Ease of use
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Guillaume Lemaire, MD
role: PRINCIPAL_INVESTIGATOR
References: