Do Respiratory Control Center Anomalies Explain the Lack of Respiratory Sensations Perceptions Observed in Patients Affected by COVID-19 ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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
排除标准
- •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.).
结局指标
主要结局
Intensity of the emotional response to hypoxic exposure (14.3 et 12.7% FIO2)
时间窗: 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)
次要结局
- Perception of a hypercapnic stimulus induced dyspnea (7% CO2)(5 minutes)
- brain MRI(1,5 hours)
- Perception of a hypoxic stimulus induced dyspnea (14.3 et 12.7% FIO2)(5 minutes)
- Perception of a inspiratory mechanical constraint induced dyspnea(5 minutes)