NCT04375774

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID

Interventions

Type	Name	Description
DEVICE	FFP2	Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI
DEVICE	Facial mask	Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI
DEVICE	MFS	Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI

Timeline

• Start date: 2020-05-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2020-05-05
• Last updated: 2020-05-05

Locations

1 site across 1 country: Belgium