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

NCT04375774 | Unknown

• 1 other identifier: 2020/15AVR/226
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Keywords

COVID; protection equipment; 3d printable valve; fit test

Outcome Measures

Primary Outcomes (1)

• Evaluation of airtightness (Fit test)

  Non inferiority claim over FFP2

  Up to 1 week

Secondary Outcomes (4)

• User Comfort

  Up to 1 week

• Breathing easiness

  Up to 1 week

• Field of view quality

  Up to 1 week

• Ease of use

  Up to 1 week

Study Arms (3)

FFP2

OTHER

Device: FFP2

Facial mask

OTHER

Device: Facial mask

Modified full-face snorkeling

OTHER

Device: MFS

Interventions

FFP2 DEVICE

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

FFP2

Facial mask DEVICE

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

Facial mask

MFS DEVICE

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

Modified full-face snorkeling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adult volunteers working in a first line healthcare service with basic knowledge of donning PPE including respirators
• females and 5 males

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Study Officials

• Guillaume Lemaire, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Lemaire, MD

CONTACT

+3227641870; guillaume.lemaire@uclouvain.be

Marco Pettinger, MD

CONTACT

00352 661 90 20 39; marco@msg.lu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolment will be a onetime selection of 10 healthy volunteers

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: May 5, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)