CRC-COVID: COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities
Study Details
Study Description
Brief Summary
The purpose of the present study is to determine whether there is a decrease in the emotional response to experimental induction of dyspnea by hypoxic stimulation in subjects with a "neurological" form of COVID-19, compared to healthy controls.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
SARS CoV-2 infection causes lung damage that can be severe enough to require artificial ventilation. Clinicians taking care of these patients are surprised by the scant respiratory sensations and emotional responses described by patients. This attenuation of respiratory interoception deprives clinicians of the usual warning signs during respiratory decompensation of dyspnea and its aggravation. It may be the result of central nerve damage. This hypothesis is bolstered by the observation that within the multiple clinical forms of COVID-19 infection there are some "neurological" forms (headache, anosmia, agueusia, dizziness, without respiratory signs and with little or no fever), that are most likely the consequence of olfactory penetration of the virus into the central nervous system (mechanism described for SARS CoV-1).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 15 COVID positive patients dyspnea rating to various dyspneic stimulus |
Other: hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint
the fraction of inspired oxygen is reduced from ~21% (room air) to 14.3 and 12.7% allowing the SpO2 to decrease to ~75%, rebreathing test allowing the PCO2 to rise to 65 mmHg, inspiratory mechanical constraint with 50 to 75% of maximum inspiratory pressure
|
| Active Comparator: 15 healthy controls dyspnea rating to various dyspneic stimulus |
Other: hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint
the fraction of inspired oxygen is reduced from ~21% (room air) to 14.3 and 12.7% allowing the SpO2 to decrease to ~75%, rebreathing test allowing the PCO2 to rise to 65 mmHg, inspiratory mechanical constraint with 50 to 75% of maximum inspiratory pressure
|
Outcome Measures
Primary Outcome Measures
- Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2) [10 minutes]
Slope of the relation between the intensity of a hypoxic stimulus to the intensity of the emotional response (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)
Secondary Outcome Measures
- Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2) [5 minutes]
ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
- Perception of a hypercapnic stimulus induced dyspnea (7% CO2) [10 minutes]
ratings of dyspnea intensity and unpleasantness during a hypercapnic stimulus (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)
- Perception of a hypercapnic stimulus induced dyspnea (7% CO2) [5 minutes]
ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable
- Perception of a inspiratory mechanical constraint induced dyspnea [10 min]
ratings of dyspnea intensity and unpleasantness during an inspiratory mechanical constraint (visual analog scale, VAS: 0 is no pain and 10 is the worst pain)
- Perception of a inspiratory mechanical constraint induced dyspnea [5 minutes]
ratings of dyspnea immediately after an inspiratory mechanical constraint induced dyspnea(Multidisciplinary Dyspnea Profile, MDP: 0 is no change and 10 is unbearable)
- brain MRI [1,5 hours]
Multimodal MRI (including anatomical MRI, resting-state functional MRI)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- adult (≥ 18 years old, unprotected);
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for COVID-19 + patients: COVID-19 + diagnosis; with quantitative or qualitative anomalies in taste and smell; first symptoms appeared in less than 21 days
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for healthy subjects: have never presented any sign of COVID ; confirmed by recent negative serology
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understanding French;
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affiliated to social security;
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having a BMI between 20 and 30;
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preferably non-smokers and in the event of recruitment difficulties, smokers but with smoking <5 packs - year
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signature of the informed consent form
Exclusion Criteria:
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respiratory signs or symptoms (rhinitis, cough, shortness of breath at rest);
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temperature above 37.5 ° C;
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existence of a chronic respiratory pathology (including asthma and COPD in the first row);
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pregnant women ;
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protected minors and adults, persons deprived of their liberty;
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not affiliated to a social security (including AME);
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contraindication to MRI (pace maker, intracranial implants, etc.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Département R3S, hôpital de la pitié-salpêtrière | Paris | France | 75013 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP200476