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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2020-05-31

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.

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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.

Conditions

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COVID

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Enrolment will be a onetime selection of 10 healthy volunteers

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FFP2

Group Type OTHER

FFP2

Intervention Type DEVICE

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

Facial mask

Group Type OTHER

Facial mask

Intervention Type DEVICE

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

Modified full-face snorkeling

Group Type OTHER

MFS

Intervention Type DEVICE

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

Interventions

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FFP2

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

Intervention Type DEVICE

Facial mask

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

Intervention Type DEVICE

MFS

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes