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

Verification of Alternative Do-it-yourself Equipment Respirators

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.

Study Overview

• Status: Unknown
• Conditions: COVID
• Intervention / Treatment: Device: FFP2; Device: Facial mask; Device: MFS

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Marco Pettinger, MD; Phone Number: 00352 661 90 20 39; Email: marco@msg.lu
    • Contact: Guillaume Lemaire, MD; Phone Number: +322764-1870; Email: guillaume.lemaire@uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Guillaume Lemaire, MD, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID; protection equipment; 3d printable valve; fit test
• Other Study ID Numbers: 2020/15AVR/226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be presented in the future manuscript

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No