Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19.
COVID-19 Pneumonia
About this trial
This is an interventional treatment trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria: - Age greater than or equal to 18 years at the time of the initial evaluation. Patient hospitalized in non-critical areas, with at least 12 hours and no more than 48 hours of hospital stay at the time of randomization with a clinical picture of severe COVID-19, according to the following: o Patient with symptoms of COVID-19, who meets ≥1 of the following criteria: Tachypnea (≥30 breaths per minute) Arterial oxygen saturation (SaO2) in ambient air (FiO2 21%) less than or equal to 93% at sea level (89% in Mexico City), with supplemental oxygen requirements ≥4 liters per minute. Arterial pressure ratio of Oxygen and Fraction of Inspired Oxygen (PaFi) <300 Pulmonary infiltrates in imaging study covering >50% of lung fields, within the last 24 to 48 hours. Administration of supplemental oxygen through a device that provides FiO2 ≥40% (nasal cannulas at a flow of 5 liters or reservoir mask The participant understands and agrees with the intervention, randomization and follow-up that will be given during hospitalization and after discharge home and signs the informed consent document prior to randomization Exclusion Criteria: The patient does not wish to participate in the study Patients in palliative care Patients with an indication for orotracheal intubation defined by the presence of at least 2 of the following criteria: Refractory hypoxemia (SaO2 <90% or PaO2 ≤60% with an oxygenation device providing FiO2 ≥60%) for ≥5 minutes without technical failure of the monitoring or oxygenation device Respiratory rate ≥35 breaths per minute Persistent clinical signs of respiratory fatigue: use of accessory muscles of respiration and thoraco-abdominal dissociation acute respiratory acidosis (PH ≤ 7.25, PaCO2 >45 mmHg) abundant respiratory secretions with inability for adequate expectoration by the patient or OR indication for orotracheal intubation due to the presence of 1 of the following criteria: Airway protection requirement: acute altered mental status (ECG <10 points) with absence of airway protection reflexes, active hemoptysis or hematemesis, or airway obstruction. Patients with hypoxemic respiratory failure presenting state unresolved shock (need for resuscitation with intravenous fluids and/or requirement for administration of vasopressors), and unstable arrhythmias (bradycardia or tachycardia) Patients with unresolved shock (resuscitation phase or norepinephrine dose ≥0.15 mcg/kg/min), and unstable arrhythmias (bradycardia or tachycardia). Agitation or acute alteration of the mental state (ECG <10 points) that do not allow the cooperation of the patient for his mobilization to the prone position Instability of the pelvis, spine, or femur from recent surgery or trauma Anatomical alterations that limit the adoption of the prone position (severe xiphoscoliosis, contractures in the extremities, other alterations). Abdominal surgery in the last 15 days Chest injury or chest surgery in the last 15 days or Pregnancy or intracranial hypertension Deep vein thrombosis in the last 2 days Cardiac pacemaker placement in the last 2 days Chest tube with air leak or recent facial trauma or surgery
Sites / Locations
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
PRONE POSITION
STANDARD TREATMENT
Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the prone position.
Patients who require supplemental oxygen through a non-invasive device (nasal cannulas or reservoir mask) in the supine position with the head of the bed between 30-60º.