COVID-19 Infection: Exploration of Respiratory Control Center Abnormalities

NCT ID: NCT04363749

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2021-01-11

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.

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).

Conditions

Covid19; Neurological Complication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

15 COVID positive patients

dyspnea rating to various dyspneic stimulus

Group Type: EXPERIMENTAL

hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint

Intervention Type: OTHER

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

15 healthy controls

dyspnea rating to various dyspneic stimulus

Group Type: ACTIVE_COMPARATOR

hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Département R3S, hôpital de la pitié-salpêtrière

Paris, , France

Countries

France

Other Identifiers

APHP200476

Identifier Type: -

Identifier Source: org_study_id