Coronaltitude - Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19
NCT ID: NCT05167357
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2021-01-13
2021-11-02
Brief Summary
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Different alterations of response to hypoxia could be observed. The virus causing COVID19, the "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), has the potential to significantly damage the nervous system and to affect cardiorespiratory functions. If SARS-CoV-2 does, similarly to MERS and SARS, induce cardiorespiratory and neurological dysfunction, then COVID19 patients may have impaired hypoxia response after infection and perform worse on the 'Richalet test' in comparison to before the illness.
Conversely, reports of high prevalence of dyspnea in patients up to 3 months after SARS-CoV-2 infection, might indicate infection-induced degenerative changes in the carotid bodies, which might lead to sensibilization of the peripheral chemoreceptors to impaired oxygenation. Possibly similar to the impact of aging and smoking on the cardiorespiratory response to hypoxia, this phenomenon of sensibilization could entail an increased hypoxic response in patients having suffered COVID-19. Accordingly, patients might perform better on the 'Richalet test' post-COVID-19 than they did before.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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COVID+ group
As the performance of the Richalet test is done by both arms, the intervention rather is the having undergone COVID19.
COVID19
Intervention in experimental group (COVID+ group) is the disease itself, compared to the control group (COVID- group). At inclusion, subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan.
Moreover, the Richalet test is a cardiorespiratory exercise test on an ergocycle (an electrically braked cycloergometer), whilst continuous measurement by a 12-lead ECG, a blood pressure cuff, a metabograph and an ear pulse oximeter. This, to assess cardiac response, ventilatory response and relevant metabolic parameters (CF, RR, SpO2, volume, BP). Subjects breathes through a mask connected to a gas mixer, which provides a gas mixture with 11,5% oxygen (corresponding to ambient air at an altitude of 4800m) in the hypoxia phases.
Control group / COVID- group
Performance of the Richalet test is done by both arms, the control in this study here is the having stayed clear of COVID19.
No interventions assigned to this group
Interventions
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COVID19
Intervention in experimental group (COVID+ group) is the disease itself, compared to the control group (COVID- group). At inclusion, subjects have been asked if they have suffered COVID19 in the 12 months before inclusion, during whichever wave, attested by a positive PCR, positive serology test or positive chest CT scan.
Moreover, the Richalet test is a cardiorespiratory exercise test on an ergocycle (an electrically braked cycloergometer), whilst continuous measurement by a 12-lead ECG, a blood pressure cuff, a metabograph and an ear pulse oximeter. This, to assess cardiac response, ventilatory response and relevant metabolic parameters (CF, RR, SpO2, volume, BP). Subjects breathes through a mask connected to a gas mixer, which provides a gas mixture with 11,5% oxygen (corresponding to ambient air at an altitude of 4800m) in the hypoxia phases.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject having stayed clear of COVID19 (COVID-/control group).
* Subject having been well informed and having provided written informed consent before participation.
* Subject covered by social security of some sort.
* Subject with an oxygen saturation of SpO2 \> 95% in ambient air on day of Richalet test performance.
* Subject presenting with no symptoms of COVID19 (anymore) on the day of the experiment.
* Subject having already performed the Richalet hypoxia exercise test as part of the altitude mountain consultation in the years 2015 to 2019 in any of the 13 hospital centers participating at the study.
Exclusion Criteria
* Subject with a history of psychiatric or behavioral disorder.
* Subject covered by L1121-5 to L1121-8 sections of the Public Health regulations (Code de la Santé Publique).
* Subject under guardian- or curatorship.
* Subject without social insurance.
* Subjet under the age of 18.
* Subject refusing to participate in the study.
* Subject diagnosed with an infection by a pathogen other than SARS-CoV-2.
18 Years
ALL
Yes
Sponsors
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University of Paris 13
OTHER
Ecole Nationale des Sports de Montagne
OTHER
Institut de Formation et de Recherche en Médecine de Montagne
OTHER
Responsible Party
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Lecoq James François
Medical Doctor, PhD. Chef de pôle urgence et médecine de montagne
Principal Investigators
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François Lecoq-Jammes, Dr.
Role: PRINCIPAL_INVESTIGATOR
study coordinator
Locations
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Institut de Formation et de Recherche en Médecine de Montagne (IFREMMONT)
Chamonix, Auvergne-Rhône-Alpes, France
Countries
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References
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Other Identifiers
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CORONALTITUDE2021
Identifier Type: -
Identifier Source: org_study_id
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