Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706039
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2021-01-08
Brief Title:
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVIDAIR
Brief Summary:
Since the start of 2020 the new SARS-CoV-2 coronavirus is causing a real global health crisis
In France nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening There are three major difficulties with this type of sampling
I It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx It causes some patients to bleed or even feel uncomfortable
II It is not easily accepted by children III It is dependent on the availability of swabs Faced with these difficulties linked to the initial sampling new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds VOCs
Due to their sensitivity and the wealth of information that can be provided the most promising techniques are based on mass spectrometry coupled with a soft ionisation system For example on-line exhaled air analysis is capable of detecting a very large number of VOCs Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations
I poor repeatabilityaccuracy in the chemical characterisation of exhaled air II too high specificity detection of only part of the emitted compounds III too limited sensitivity IV and poor adaptation to be deployed in a clinic
In order to overcome these various limitations we propose the use of a new generation of mass spectrometer Vocus PTR-TOF The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer PTR-MS developed for the detection in real time of trace VOCs in industrial environments laboratories or directly in the environment This new generation of instrument offers the following advantages
I unequalled sensitivity
II a robust ionisation system not affected by environmental conditions relative humidity III a high mass resolution allowing precise identification of compounds IV a compact and durable architecture allowing deployment in a constrained environment such as hospital airport The sensitivity and speed of measurement allow the expiration process to be monitored in real time bringing an additional dimension to the measurement and the chances of success
In France nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening There are three major difficulties with this type of sampling
I It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx It causes some patients to bleed or even feel uncomfortable
II It is not easily accepted by children III It is dependent on the availability of swabs Faced with these difficulties linked to the initial sampling new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds VOCs
Due to their sensitivity and the wealth of information that can be provided the most promising techniques are based on mass spectrometry coupled with a soft ionisation system For example on-line exhaled air analysis is capable of detecting a very large number of VOCs Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations
I poor repeatabilityaccuracy in the chemical characterisation of exhaled air II too high specificity detection of only part of the emitted compounds III too limited sensitivity IV and poor adaptation to be deployed in a clinic
In order to overcome these various limitations we propose the use of a new generation of mass spectrometer Vocus PTR-TOF The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer PTR-MS developed for the detection in real time of trace VOCs in industrial environments laboratories or directly in the environment This new generation of instrument offers the following advantages
I unequalled sensitivity
II a robust ionisation system not affected by environmental conditions relative humidity III a high mass resolution allowing precise identification of compounds IV a compact and durable architecture allowing deployment in a constrained environment such as hospital airport The sensitivity and speed of measurement allow the expiration process to be monitored in real time bringing an additional dimension to the measurement and the chances of success
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None