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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Verification of Alternative Do-it-yourself Equipment Respirators

Conditions
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COVID

Intervention / Treatment
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* Device: FFP2
* Device: Facial mask
* Device: MFS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Enrolment will be a onetime selection of 10 healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FFP2<br> | Device: FFP2<br>* Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI<br>|
| Other: Facial mask<br> | Device: Facial mask<br>* Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI<br>|
| Other: Modified full-face snorkeling<br> | Device: MFS<br>* Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of airtightness (Fit test) | Non inferiority claim over FFP2 | Up to 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Breathing easiness | User respiratory easiness for each type of mask assessed by a scoring-cale from 1 to 5 | Up to 1 week | 
| 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 | 
| Ease of use | How the device is user friendly, assessed by a scoring-cale from 1 to 5 | Up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, protection equipment, 3d printable valve, fit test