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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04379154
Other study ID # 2020_0060
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2020
Est. completion date June 1, 2021

Study information

Verified date January 2022
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study of volatile organic compounds (VOCs) detected in exhaled air is an innovative research area for respiratory diseases. This analysis can be done by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOCs without identifying them. The VOCs in exhaled air in patients hospitalized for COVID-19 infection are analysed in this study, using electronic noses.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients infected by SARS-CoV-2 whose medical condition warrants hospitalisation (out of intensive care) for oxygen therapy less or equal to 4 l/min - Patients must be 18 years of age or older - Fluent in the French language - Have signed a consent form - Being affiliated with healthcare insurance Exclusion Criteria: - Pregnant woman - Patient deprived of liberty by judicial or administrative decision

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Volatile Organic Compounds analysis
Volatile Organic Compounds analysis in exhaled air by electronic noses

Locations

Country Name City State
France Hôpital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Profiles of volatile organic compounds (VOCs) in exhaled air between 2 health conditions Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled). The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between patients who improve and patients who get worse during their hospitalisation for COVID-19 infection 1 day
Secondary Profiles of volatile organic compounds (VOCs) in exhaled air on 1 health condition Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the start and the discharge to the hospital in patients infecting and recovering from COVID-19. 2 weeks
Secondary Profiles of volatile organic compounds (VOCs) in exhaled air between 2 periods Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from electronic noses (a set of sensors interacting with the VOCs exhaled. The analysis of the generated signal (resistance or load variations) is characteristic of the composition of VOCs), between the hospitalisation period and a post-hospitalisation follow-up consultation in patients infected by COVID-19 and recovered. 4 months
Secondary Profiles of volatile organic compounds (VOCs) in exhaled air by mass spectrometry at each visit based on patient evolution status. Comparison of variation of profiles of Volatile Organic Compounds in exhaled air from mass spectrometry, at hospitalisation, post-hospitalisation and follow-up consultation in patients infected by COVID-19 and recovered. 4 months
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