Randomized, study to evaluate early prone position in patients with COVID-19

Not Applicable

• Conditions: Coronavirus infections; Respiratory Distress Syndrome, Adult; C01.925.782.600.550.200; C08.381.840

• Registration Number: RBR-2k66ft
• Lead Sponsor: Rodrigo S Biondi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find a reduction in the intubation rate in the group undergoing prone positioning in 14 days.<br>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.<br>The primary outcomes will be evaluated by Bayesian logistic regression models and the results presented by the odds ratios.