Besides protective ventilation with low tidal volumes, prone positioning is a proven intervention to decrease mortality in mechanically ventilated patients with moderate-severe acute respiratory distress syndrome. However, the evidence of this strategy in awake non-intubated patients is scarce. The investigators will perform a randomized controlled trial to define if prone positioning can reduce the requirement of mechanical ventilation.
Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the treatment of moderate/severe disease is mainly supportive, including oxygen therapy and invasive mechanical ventilation when impending respiratory failure is established. Moreover, the associated mortality among mechanically intubated patients is overwhelmingly high. Prone position relieves the dependent lung regions from the compressive forces of the mediastinum's weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung regions. According to a few case series, and observational non-randomized studies with small sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during prone positioning, however there are no clinical evidence that this improvement is associated with a decrease in the risk of invasive mechanical ventilation. Considering that prone positioning is a low cost, low risk and widely available therapy, more high quality evidence is needed, to determine if the benefits of prone positioning in awake patients also include a lower requirement of mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.
Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Hospital General de Occidente
Guadalajara, Jalisco, Mexico
Intubation rate
Time frame: 28 days
Total hours of prone position at day
Time frame: 28 days
Total number of prone sessions at day
Time frame: 28 days
Hours of the longest prone session each day
Time frame: 28 days
Change in oxygenation 1-hour after first prone session
Time frame: 1 hour
Change in the ROX-index 1-hour after first prone session
The change in the Ratio of Oxygen saturation to respiratory rate (ROX-index)
Time frame: 1 hour
Total days of prone positioning therapy
Time frame: 28 days
Adverse effects of prone positioning therapy
Time frame: 28 days
Mechanical ventilation days
Time frame: 28 days
Intensive care unit length of stay
Time frame: 28 days
Hospital length of stay
Time frame: 28 days
Hospital mortality
Time frame: 28 days
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