Status:
TERMINATED
Early Awake Alterning Prone Positioning Combined With Non-invasive Oxygen Therapy in Patients With COVID-19.
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: The disease caused by the new coronavirus (COVID-19) represents a pandemic with significant affectation in our country, generating critical illness in around 5% of the patients who prese...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT06076109
Start Date
March 1 2021
End Date
April 30 2022
Last Update
October 10 2023
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 16310