Emerging respiratory diseases represent a global threat. Viruses such as influenza andcoronaviruses have been the main drivers of pandemics over the past century. Morebroadly, the impact of these respiratory infections is not limited to pandemic risks.Indeed, some of them also trigger seasonal epidemics with a significant medical andeconomic burden. Consequently, it is essential to strengthen global surveillance, anddiagnostic capacities for the pathogens responsible for respiratory infections.The diagnosis of respiratory infections is even more important in cases of severeinfection, as it helps guide and adapt patient management according to the responsiblepathogen.A promising and well-recognized approach is the analysis of exhaled breath, whichcontains a complex mixture of volatile organic compounds (VOCs), also known as the"volatilome." The volatilome is influenced by the patient's metabolism, immune system,and microbiome, and can be disrupted by the presence of a pathogen.A parallel clinical study, VORTEX-1, aims to establish the performance of breath analysisfor the diagnosis of respiratory infections in the context of the general population, orpatient triage in emergency wards. This study targets patients with non-severerespiratory infections, mostly caused by viral pathogens.Thanks to a specific technique, the VORTEX-1 study will make it possible to test a directon-site sampling and analysis process, painless and with real-time chemical detection.This methodology, highly suited to triage situations, remains difficult to apply in thecase of respiratory infections requiring hospitalization. Indeed, hospitalized patientsare usually admitted to different units depending on their clinical status, risk factors,or bed availability. This diversity of settings makes it impossible to implement aprocess that depends on an instrument which cannot be available or moved in real timeacross all units. To address this challenge, the investigators will use an alternativemethod.In the VORTEX-2 trial, samples of exhaled gases will be collected directly at thepatient's bedside using a single-use device for breath collection. The samples will thenbe transferred to a laboratory for analysis. This approach is more suitable for severerespiratory infections.To be as comprehensive as possible in the study of the volatilome in the context ofrespiratory infections, it is important to include hospitalized patients and to develop asystem that can also be implemented in routine clinical practice.The link between the two studies (VORTEX-1 and VORTEX-2) will be established through a"control" group, consisting of healthy subjects (without respiratory infections orsevere/chronic diseases), whose breath will be collected using both approaches.
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Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
The collection and analysis of exhaled air for VOC detection is a non-invasive, painless
procedure carried out offline. It can be summarised as follows:
1. Collection of 0.5-1 litre of exhaled air in a single-use Tedlar® bag
2. Transfer the exhaled air sample to a thermodesorption tube. The thermodesorption
tube will be sent to the laboratory responsible for the analysis within 1-5 days of
collection.
3. The breath sample will be analysed in the laboratory using thermal desorption-GC/MS.
4. Processing of the raw data to determine the chemical composition of VOCs and
identify the compounds present in the exhaled air sample.
5. Statistical analysis of all generated data will be performed to identify interesting
VOC profiles.
Inclusion Criteria:
- Age ≥ 18 years old
- Having signed a written informed consent
- Presenting a NEWS-2 score of 5 (>4) or one of the individual score criteria rated 3
- Hospitalized in one of the HCL (Hospices Civils de Lyon) departments participating
in the study
- With clinical signs of acute respiratory infection, or with a clinical presentation
of acute community-acquired pneumonia, nasopharyngitis, angina or laryngitis (except
for healthy patients)
Exclusion Criteria:
- Healthy volunteers:
- Age: < 18 years
- Alcohol consumption less than 12 hours
- Person with co-morbidities such as chronic respiratory failure, type II diabetes,
cancerous processes, chronic liver disease, chronic kidney disease
- Clinical signs of acute respiratory infection
- Persons who are unable to blow into exhaled-air analysis devices (in accordance with
instructions for use)
- Persons under legal protection
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar
scheme
- Patients with respiratory symptoms
- Age: < 18 years
- Patients whose symptoms have been present for more than 7 days
- Persons unable to blow into the device for breath analysis (in accordance with the
operating instructions)
- Patients suffering from cystic fibrosis
- Patients with severe chronic respiratory insufficiency requiring long-term oxygen
therapy or NIV (non-invasive ventilation), excluding CPAP (Continuous Positive
Airway Pressure) for sleep apnea
- Patients under legal protection
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar
scheme
Emergency department (Hôpital de la Croix-Rousse, Hospices Civils de Lyon)
Lyon, France
Infectious Disease Service of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, France
Intensive Care Unit of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, France
Intensive Care Unit of Hôpital Lyon Sud (Hospices Civils de Lyon)
Lyon, France
Internal Medecine Unit of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, France
National reference center for respiratory viruses (Hôpital de la Croix-Rousse, Hospices Civils de Lyon)
Lyon, France
Pneumology Unit of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, France
Dr Alexandre GAYMARD
+4 72 07 10 53
alexandre.gaymard@chu-lyon.fr
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