COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities

Covid19 Clinical Trial

— CRC-COVID  

Official title:

Do Respiratory Control Center Anomalies Explain the Lack of Respiratory Sensations Perceptions Observed in Patients Affected by COVID-19 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363749
• Other study ID #: APHP200476
• Status: Completed
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: August 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - adult (= 18 years old, unprotected);
• for COVID-19 + patients: COVID-19 + diagnosis; with quantitative or qualitative anomalies in taste and smell; first symptoms appeared in less than 21 days
• for healthy subjects: have never presented any sign of COVID ; confirmed by recent negative serology
• understanding French;
• affiliated to social security;
• having a BMI between 20 and 30;
• preferably non-smokers and in the event of recruitment difficulties, smokers but with smoking <5 packs - year
• signature of the informed consent form

Exclusion Criteria:

• respiratory signs or symptoms (rhinitis, cough, shortness of breath at rest);
• temperature above 37.5 ° C;
• existence of a chronic respiratory pathology (including asthma and COPD in the first row);
• pregnant women ;
• protected minors and adults, persons deprived of their liberty;
• not affiliated to a social security (including AME);
• contraindication to MRI (pace maker, intracranial implants, etc.).

Related Conditions & MeSH terms

• Covid19
• Neurological Complication

Intervention

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

Locations

Country	Name	City	State
France	Département R3S, hôpital de la pitié-salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)	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)	10 minutes
Secondary	Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)	ratings of dyspnea immediately after a hypoxic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable	5 minutes
Secondary	Perception of a hypercapnic stimulus induced dyspnea (7% CO2)	ratings of dyspnea intensity and unpleasantness during a hypercapnic stimulus (visual analog scale, VAS : 0 is no pain and 10 is the worst pain)	10 minutes
Secondary	Perception of a hypercapnic stimulus induced dyspnea (7% CO2)	ratings of dyspnea immediately after a hypercapnic stimulus: Multidisciplinary Dyspnea Profile, MDP : 0 is no change and 10 is unbearable	5 minutes
Secondary	Perception of a inspiratory mechanical constraint induced dyspnea	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)	10 min
Secondary	Perception of a inspiratory mechanical constraint induced dyspnea	ratings of dyspnea immediately after an inspiratory mechanical constraint induced dyspnea(Multidisciplinary Dyspnea Profile, MDP: 0 is no change and 10 is unbearable)	5 minutes
Secondary	brain MRI	Multimodal MRI (including anatomical MRI, resting-state functional MRI)	1,5 hours