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

NCT04375774 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-05-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Guillaume Lemaire, MD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375774 on ClinicalTrials.gov