Coronavirus infections
Conditions
Interventions
Prone position in awake patients for 3h up to 3 times a day. Positioning will be performed with the assistance and under the supervision of a physical therapist.
Putting the patient in a prone positio
Procedure/surgery
G11.427.410.698.840
Sponsors
Rodrigo S Biondi
Rodrigo S Biondi
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with COVID-19 confirmed by RT-PCR or strong suspicion, defined as both typical clinical picture and typical chest CT scan. Presence of bilateral infiltrate on chest tomography and one of the following two: Patient with SpO2 below 94% in room air or Need for O2 by nasal catheter above 4L per min to maintain SpO2 above 94%
Exclusion criteria
Exclusion criteria: Denial of the patient or physician or assistant team to participate in the study. Evident signs of ventilatory fatigue (RF greater than 30irpm, PaCO2 greater than 45mmHg, with pH less than 7.35 and use of evident accessory musculature with indication of imminent intubation # Need more than 5 EPAP and 5 IPAP in NIV. Hemodynamic instability (need for Noradrenaline above 0.3mcg per kg per min). Respiratory failure (IRPA) with estimated intubation in the next 6 hours. Cervical, sternotomy or facial surgery less than 15 days ago. Impossibility of collecting arterial blood gases. Evidence or strong suspicion of a cause of IRPA other than COVID pneumonia. Disorientation. Pregnant women with a pregnant abdomen. Have participated in the study previously. Exclusive palliative care. Any clinical impossibility of prone position such as instability or fracture of the spine, pelvis or femur; Massive hemoptysis in need of surgical intervention; Anterior thoracic drain with air leak; Presence of pacemaker installed less than 2 days ago
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the intubation rate in the group undergoing prone positioning in 14 days. The primary outcomes will be evaluated by Bayesian logistic regression models and the results presented by the odds ratios.;It is expected to find a reduction in mortality in the group undergoing prone positioning in 14 days. The primary outcomes will be evaluated by Bayesian logistic regression models and the results presented by the odds ratios. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the validity of the ROX index in this population. All binary secondary outcomes (such as hospital death and death in the ICU) will be assessed by Bayesian logistic regression models and the results presented by the odds ratios. Continuous secondary outcomes will be presented by mean and standard deviation, or median and quartiles, when appropriate. And they will be tested by generalized linear Bayesian models considering distributions that best fit the data.;Identify predictive factors for orotracheal intubation. Secondary binary outcomes (such as hospital death and death in the ICU) will be assessed by Bayesian logistic regression models and the results presented by the odds ratios. Continuous secondary outcomes will be presented by mean and standard deviation, or median and quartiles, when appropriate. And they will be tested by generalized linear Bayesian models considering distributions that best fit the data.;To evaluate the effectiveness of the prone position in relation to the time for intubation and time on mechanical ventilation, due to the possible reduction in P-SILI. Secondary binary outcomes (such as hospital death and death in the ICU) will be assessed by Bayesian logistic regression models and the results presented by the odds ratios. Continuous secondary outcomes will be presented by mean and standard deviation, or median and quartiles, when appropriate. And they will be tested by generalized linear Bayesian models considering distributions that best fit the data. | — |
Countries
Brazil
Contacts
Public ContactRodrigo Biondi
Hospital Brasília
Outcome results
None listed