We hypothesize that exhaled breath analysis by eNose is able to discriminate between patients with and without Covid-19 at point of care.
ID
Bron
Verkorte titel
Aandoening
COVID
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary Objectives:
To determine the diagnostic accuracy of exhaled breath analysis by eNose at point of care
for discrimination between healthy controls and individuals with respiratory symptoms with
and without a Covid-19 infection.
Achtergrond van het onderzoek
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 three to four 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.
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 with and without Covid-19 at point
of care.
Study design:
Prospective, observational, cross-sectional single-centre pilot study
Study population:
Individuals with a suspected diagnosis of Covid-19 infection.
Main study parameters/endpoints:
Exhaled breath profiles obtained by sampling exhaled air using real time eNose technology.
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.
Doel van het onderzoek
We hypothesize that exhaled breath analysis by eNose is able to discriminate between
patients with and without Covid-19 at point of care.
Onderzoeksopzet
day 0 and 30
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All newly presented individuals (>18 years of age) and health care personnel with a
suspected diagnosis of Covid-19 infection.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Recent (< 12 hours) intake of alcohol;
- Unwillingness or inability to comply with the study protocol for any other reason.
Opzet
Deelname
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Register | ID |
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NTR-new | NL8694 |
Ander register | METC LUMC : P20.033 |