Primary Objective: Assess the leakage of FFP2 respirators and surgical masks in human subjects using inhalable aerosols consisting of a solution of fluorescein in water.Secondary Objective(s): (a) Study the variability in total inward leakage of…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total inward leakage, expressed as a percentage of the dose, based on the
recovery of fluorescein tracer in saliva and urine following exposure to finely
dispersed spray of inhalable aerosols with fluorescein dissolved in water.
Secondary outcome
Total inward leakage, expressed as a percentage of the dose, is based on the
recovery of fluorescein tracer in the mask filters and skin wipes following
exposure to finely dispersed spray of inhalable aerosols with fluorescein
dissolved in water. The influence of facial hair length on total inward leakage
in males will be analyzed by comparing leakage between different beard lengths
(0 mm, 5 mm and 10 mm).
Background summary
In healthcare, respiratory protective equipment (RPE), especially face masks,
has become indispensable to mitigate infection risk. The availability of
good-quality RPE requires adequate efficacy testing. However, current testing
protocols for RPE rely on the use of solid particles as a model for toxic
exposures rather than liquid aerosols that carry airborne viruses.
Additionally, there is limited understanding of interindividual differences in
protection due to variations in face size and shape, as well as facial hair
growth, which may change face seal fit and overall protection efficacy. This
study aims to evaluate a new approach to assess the efficacy of face masks
using fluorescein in water as a tracer to evaluate the total inward leakage of
FFP2 respirators and surgical masks in a controlled laboratory study using
inhalable liquid aerosols.
Study objective
Primary Objective: Assess the leakage of FFP2 respirators and surgical masks in
human subjects using inhalable aerosols consisting of a solution of fluorescein
in water.
Secondary Objective(s): (a) Study the variability in total inward leakage of
FFP2 respirators and surgical masks in a small group of males and females, and
(b) Evaluate the effect of facial hair growth on the total inward leakage in
males.
Study design
In a controlled laboratory setting, healthy subjects will be exposed to a
finely dispersed spray of inhalable aerosols containing a fluorescein solution
in water to quantify face mask leakage.
Intervention
Exposure to a finely dispersed spray of aerosols containing 10% fluorescein
sodium in a 5 mL water solution, without and while wearing an FFP2 respirator
or surgical mask.
Study burden and risks
Human subjects will be asked to participate in three or five visits lasting two
hours each. These events involve the nebulization of a fluorescein solution
while wearing either an FFP2 respirator or surgical mask. Human subjects will
be asked to complete a questionnaire regarding general information and to
provide saliva and urine samples. The risk of this study is negligible, as the
exposure level will not exceed that typically used in medical diagnostic
procedures with fluorescein. There are no benefits for human subjects.
Heyendaalseweg 135
Nijmegen 6525 AJ
NL
Heyendaalseweg 135
Nijmegen 6525 AJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a human subject must meet
all of the following criteria:
- Healthy males and females
- Aged 18-60 years at the time of inclusion
- European (Caucasian) or Asian descent
- No history of atopic disorders
- No facial hair growth or shaved.
Exclusion criteria
A potential human subject 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 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
- Male with facial hair growth unwilling to shave it (beards and/or
moustaches).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL87018.091.24 |