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

Verification of Alternative Do-it-yourself Equipment Respirators

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04375774
Acronym
VADER
Enrollment
10
Registered
2020-05-05
Start date
2020-05-31
Completion date
2020-05-31
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID

Keywords

COVID, protection equipment, 3d printable valve, fit test

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.

Interventions

DEVICEFFP2

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

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

DEVICEMFS

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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Enrolment will be a onetime selection of 10 healthy volunteers

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of airtightness (Fit test)Up to 1 weekNon inferiority claim over FFP2

Secondary

MeasureTime frameDescription
User ComfortUp to 1 weekUser face comfort for each type of mask assessed by a assessed by a scoring-cale from 1 to 5
Breathing easinessUp to 1 weekUser respiratory easiness for each type of mask assessed by a scoring-cale from 1 to 5
Field of view qualityUp to 1 weekUser field of view quality for each type of mask assessed by a scoring-cale from 1 to 5
Ease of useUp to 1 weekHow the device is user friendly, assessed by a scoring-cale from 1 to 5

Countries

Belgium

Contacts

Primary ContactGuillaume Lemaire, MD
guillaume.lemaire@uclouvain.be+3227641870
Backup ContactMarco Pettinger, MD
marco@msg.lu00352 661 90 20 39

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026