Coronavirus Infections
Conditions
Interventions
The treatment will be carried out during the hospitalization of patients at Lydia Storopoli Hospital. A physiotherapist will go to the patients bedside and position the non-invasive vagus nerve stimul
Sponsors
Universidade Nove de Julho
Centro de Neuromulação Spaulding
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age; confirmed diagnosis of COVID-19 from moderate to severe; be able to understand the stimulation treatment that will be performed, receiving supplemental oxygen, non-invasive ventilation, but without being intubated
Exclusion criteria
Exclusion criteria: cochlear implant; have uncontrolled diabetes and hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammatory panel To analyze the inflammatory panel, interleukin 6 (IL-6), interleukin-10, cortisol and C-reactive protein (CRP) will be analyzed. Blood samples will be collected by venipuncture. The blood (15 ml) will be collected in a tube containing protease inhibitor and EDTA and will be immediately centrifuged (3000 rpm, 15 min, 4 ° C). The plasma will be transferred to microcentrifuge tubes (1.5 ml) and stored at -80 ° C until analysis. The concentrations of IL-6, IL-10 and cortisol will be measured in plasma by the ELISA method (Enzyme-Linked Immuno-Sobent Assay) and competitive chemiluminescent immunoassay following the manufacturer's recommendations. The ELISA plates will be sensitized with 100 g / ml of the capture antibody to IL-6, IL-10 and cortisol (Human Quantikine ELISA Kit D6050, Human Quantikine ELISA Kit D100B and cortisol parameter KGE008B) and incubated overnight at 4 ° C. The plates will be washed the next day using a washing solution (PBS 0.05% Tween 20). IL-6 plates will be blocked and incubated for two hours at room temperature. After incubation, the plates will be washed again and the standard curves will be added. The curves will start at 8,000 pg / ml. The plates will be incubated for two hours at room temperature and, at the end, they will be washed. Detection antibodies to IL-6 will be added, and the plates will be incubated again at room temperature for two hours, and washed after that time. Then, streptavidin-HRP will be added at a dilution of 1/200, and the plates will be incubated for 20 minutes at room temperature, being washed after finishing. Substrate (urea peroxide and TMB, 1/1 proportion) will be added, which will develop a color proportional to the antigen present in the sample. This reaction will be blocked by the addition of stop solution (H2SO4 2M), and the intensity of that color will be measured immediately in the ELISA reader, using a wavelength of 450nm. Quantitative determination of CRP will be performed by nephelomet | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular parameters The cardiovascular parameters analyzed will be blood pressure and heart rate variability. Brachial blood pressure will be assessed using an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan). Assessment will be obtained at supine position after a ten-minute resting. Three consecutive measurements will be taken on both arms, using an appropriate cuff size for the arm circumference. Three assessments in each arm will be obtained and the average of the last two measurements will be used16. Heart rate variability will be used to assess cardiac autonomic modulation. With patients in the supine position, RR intervals will be recorded for 10 minutes using a heart rate monitor (V800, Polar Electro, Finland). After collection, RR intervals will be exported to the Kubios HRV program (Version 2.0, Biosignal Analysis and Medical Imaging Group, Finland). The time-domain parameters obtained will be the standard deviation of all RR intervals (SDNN), the square root of the square mean of the differences between the adjacent normal RR intervals (RMSSD), and the percentage of adjacent intervals over 50ms (PNN50). The frequency-domain parameters will be obtained by the spectral analysis using the autoregressive method. The frequencies between 0.04 and 0.4 Hz will be considered as physiologically significant, with the low-frequency component being represented by oscillations between 0.04 and 0.15 Hz and the high-frequency component between 0, 15, and 0.4 Hz (Task Force Heart rate variability). Sympathetic responsiveness will be assessed by the blood pressure and heart rate responses during the handgrip test. Initially, maximum voluntary contraction will be assessed through the largest handgrip performed in three attempts. Subsequently, patients will perform the handgrip exercise for two minutes at an intensity of 30% of the maximum voluntary contraction. Before and in the final 30 seconds of the test, blood pressure and heart rate will be | — |
Countries
Brazil
Contacts
Public ContactFernanda Corrêa
Outcome results
None listed