Viral infectious diseases
Conditions
Interventions
Participants will wear either a surgical mask or an FFP2 respirator. To quantify TOL, a non-toxic fluorescent tracer (fluorescein in water) will be used. The tracer method has previously been applied
Sponsors
Radboud Universiteit Nijmegen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: - Healthy (for the first phase of the study) and infected [1] (for the second phase of the study) males and females. - No facial hair growth or shaved for the first phase of the study or willing to shave to certain length for second phase of the study. - European (Caucasian) and Asian descent [2]- Aged 18-60 years at the time of inclusion. [1] Interested participants who suspect a respiratory viral infection may contact the research team. During intake at the research facility, a throat and nasal swab will be collected to confirm infection and identify the type of virus. [2] This criterion is based on observed biometric differences that may influence the fit and performance of the masks being tested. These differences are important for our research as they may impact mask fit and effectiveness. It is essential to clarify that this inclusion criterion is based solely on biometric factors and is not intended to exclude individuals of other descents. This decision is made to ensure the scientific validity of the study.
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: - Unable to complete the informed consent procedure independently. - Individuals with medical and/or cosmetic surgery that altered the form of their face. - Individuals who are medically unfit to wear a standard face mask (e.g., due to airway diseases such as COPD or asthma, or skin reaction). - Individuals with a history of atopic constitution, as defined by the European Community Respiratory Health Survey (ECRHS) questionnaire. - Individuals with a history of exposure to fluorescein. This includes intravenous administration of fluorescein for imaging purposes (such as fluorescein angiography) or local administration of fluorescein in the eye for corneal damage diagnostics. - Pregnancy or (partner) intention to become pregnant during the study period. - Nursing mothers. - Male with facial hair growth unwilling to shave it (beards and/or moustaches). - Individuals with a history of cardiovascular or pulmonary disease (e.g., chronic bronchitis, heart failure, ischemic heart disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is TOL, quantified by measuring the concentration of fluorescein in the air using Gromoz high-volume samplers. The study will assess the TOL across repeated measurements and between different face mask types (surgical mask vs. FFP2 respirator). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is TOL, quantified by measuring the concentration of fluorescein in the mask filters. The influence of facial hair length on TOL in males will be analyzed by comparing leakage between different beard lengths (0 mm, 5 mm and 10 mm). | — |
Countries
Netherlands
Contacts
Public ContactK Lassing
Radboud Universiteit Nijmegen
Outcome results
None listed