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

Not Applicable

• Conditions: COVID
• Interventions: Device: Facial mask; Device: FFP2; Device: MFS

• Registration Number: NCT04375774
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2020-04-17
• Status Verified: 2020-05
• Study Start: 2020-05
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Study First Submitted QC: 2020-05-04
• Last Update Submitted: 2020-05-04
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Facial mask	Facial mask	-
FFP2	FFP2	-
Modified full-face snorkeling	MFS	-

Primary Outcome Measures

Name	Time	Method
Evaluation of airtightness (Fit test)	Up to 1 week	Non inferiority claim over FFP2

Secondary Outcome Measures

Name	Time	Method
User Comfort	Up to 1 week	User face comfort for each type of mask assessed by a assessed by a scoring-cale from 1 to 5
Breathing easiness	Up to 1 week	User respiratory easiness for each type of mask assessed by a scoring-cale from 1 to 5
Ease of use	Up to 1 week	How the device is user friendly, assessed by a scoring-cale from 1 to 5
Field of view quality	Up to 1 week	User field of view quality for each type of mask assessed by a scoring-cale from 1 to 5

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium