Objective: The overall aim of this pilot study is to determine the diagnostic accuracy of exhaled breath analysis by eNose for the discrimination between patients and health care workers with and without Covid-19 at point of care.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints:
Exhaled breath profiles obtained by sampling exhaled air using real time eNose
technology to determine COVID-19 infection
Secondary outcome
To assess the accuracy of exhaled breath analysis by eNose at baseline for
discrimination between individuals with different disease progression (e.g.
mild respiratory symptoms, ICU admission and death).
Background summary
Rationale:
The World Health Organization (WHO) has recently characterized novel
coronavirus (Covid-19) as a pandemic due to its rapid spread and severity.
Common clinical symptoms of the disease include fever, cough, shortness of
breath. However, in some patients the disease progresses to more severe
outcomes as such pneumonia, progressive respiratory failure and even death.
Currently, a Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) test is
used to detect the virus using e.g. sputum samples. However, results of the
test are often available after one to three days. Therefore, there is an urgent
need for a diagnostic tool with a rapid turnaround time in processing Covid-19
test results and identify patients with higher risk of fatal outcomes. Exhaled
breath analysis using eNose technology linked to a cloud solution may qualify
for this.
Study objective
Objective:
The overall aim of this pilot study is to determine the diagnostic accuracy of
exhaled breath analysis by eNose for the discrimination between patients and
health care workers with and without Covid-19 at point of care.
Study design
Study design:
Prospective, observational, cross-sectional multi-centre pilot study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
As this concerns observational research using exhaled breath, no direct risk is
involved with participation in this study. Participation in this study does not
affect the subjects* regular care.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
acute respiratory tract infection, COVID-19 infection
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Recent (< 12 hours) intake of alcohol
- Unwillingness or inability to comply with the study protocol for any other
reason
In order to increase the applicability in clinical practice, there are no
further restrictions.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73555.058.20 |