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

COVID Clinical Trial

— VADER  

Official title:

Verification of Alternative Do-it-yourself Equipment Respirators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375774
• Other study ID #: 2020/15AVR/226
• Status: Recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Guillaume Lemaire, MD
• Phone: +3227641870
• Email: guillaume.lemaire[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

Device:
• FFP2
Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI
• Facial mask
Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI
• MFS
Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of airtightness (Fit test)	Non inferiority claim over FFP2	Up to 1 week
Secondary	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
Secondary	Breathing easiness	User respiratory easiness for each type of mask assessed by a scoring-cale from 1 to 5	Up to 1 week
Secondary	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
Secondary	Ease of use	How the device is user friendly, assessed by a scoring-cale from 1 to 5	Up to 1 week