Prone position (placing the patient on his abdomen) has been shown to be an effective intervention to decrease mortality in adults connected to mechanical ventilation for moderate to severe Acute Respiratory Distress Syndrome (ARDS). Patients may require one or more sessions of prone position. However, the optimal duration of prone sessions is unknown. The goal of this clinical trial is to learn if applying prone position in prolonged sessions (\> 48 hours - prolonged prone position) is more effective than applying it in daily sessions (16 to 24 hours - intermittent prone position). The trial will also learn about the safety of prolonged prone position compared to intermittent prone position. The main questions it aims to answer are:
* Does prolonged prone position increase survival compared to intermittent prone position in participants with moderate to severe ARDS ? * How does prolonged prone position compare to intermittent prone position in terms of medical problems associated to prone position ?
Researchers will compare prolonged versus intermittent prone position to see which approach is better to treat moderate to severe ARDS.
Participants will:
* Receive prone position either in prolonged (\> 48 hours) or daily (16 to 24 hours) sessions during the first 7 days * Be followed for up to 90 days to assess their clinical evolution
Age ≥ 18 years
Endotracheal intubation and mechanical ventilation for less than 72 hours
Within 1 week of a known clinical insult or new or worsening respiratory symptoms
Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules
Contraindications for prone positioning such as intracranial pressure > 20 mmHg, massive hemoptysis, recent tracheal surgery or sternotomy or abdominal surgery with an open wound, recent facial trauma or facial surgery, unstable spine, femur, or pelvic fractures, or a single anterior chest tube with air leaks
Patient on extracorporeal membrane oxygenation (ECMO) before randomization
Chronic respiratory failure requiring oxygen therapy or non-invasive ventilation (NIV)
Known pregnancy
Parallel
Daily prone position sessions
Procedure/SurgeryProne position sessions will be extended at least 16 hours, but no longer than 24 hours. Prone sessions will be repeated if PaO2/FiO2 ratio decreases to \< 150 after returning to supine position within the first 7 days after randomization. The extension of repeated prone sessions will follow the same criteria.
Prolonged prone position sessions
Procedure/SurgeryProne position sessions will be extended at least 48 hours AND until PaO2/FiO2 ratio is ≥ 200, but no longer than 120 hours. Prone sessions will be repeated if PaO2/FiO2 ratio decreases to \< 150 after returning to supine position within the first 7 days after randomization. The extension of repeated prone sessions will follow the same criteria.
28-day mortality
All-cause mortality
90-day mortality
All-cause mortality
Ventilator-free days
Days-free from mechanical ventilation and alive up to day 28
Hospital-free days at day 28
Days-free from Hospital and alive up to day 28
Click on the lead sponsor to view all of their trials.
Pontificia Universidad Catolica de Chile
Lead sponsor
Hospital do Coracao
Collaborator
Fundacion Clinica Valle del Lili
Collaborator
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Collaborator