Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS
Recruiting now · Not applicable
Conditions studied: Acute Respiratory Distress Syndrome
In brief
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
Key facts
- Study ID
- NCT06854627
- Run by
- Pontificia Universidad Catolica de Chile
- People needed
- 780
- Starts
- 2025-04-07
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Endotracheal intubation and mechanical ventilation for less than 72 hours
- Moderate-severe ARDS defined as:
- 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
- Respiratory failure not fully explained by cardiac failure or fluid overload
- PaO2/FiO2 < 150 mmHg in supine position
- Prone positioning has been indicated by the attending physician, OR has already been initiated within the last 16 hours
You may not qualify if…
- 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
- Anticipating withdrawal of life support or shift to palliative care
Where it is running
- Hospital Britanico — Buenos Aires, Argentina (enrolling)
- Sanatorio Güemes — Buenos Aires, Argentina (enrolling)
- Sanatorio Mitre — Buenos Aires, Argentina (enrolling)
- Hospital San Martin de la Plata, Argentina — La Plata, Argentina (enrolling)
- Hospital Vera Barros — La Rioja, Argentina (enrolling)
- Hospital Privado de comunidad — Mar del Plata, Argentina (enrolling)
- Hospital Leonardo Guzmán — Antofagasta, Chile (enrolling)
- Hospital Clínico Herminda Martín — Chillan, Chile (enrolling)
- Hospital Guillermo Grant Benavente — Concepción, Chile (enrolling)
- Hospital San Juan de Dios de Curicó — Curicó, Chile (enrolling)
- Hospital Regional Dr. Ernesto Torres Galdames — Iquique, Chile (enrolling)
- Complejo Asistencial Dr. Victor Ríos Ruiz — Los Ángeles, Chile (enrolling)
- Hospital Base San Jose de Osorno — Osorno, Chile (enrolling)
- Hospital de Quilpué — Quilpué, Chile (enrolling)
- Hospital Franco Ravera Zunino — Rancagua, Chile (enrolling)
- Clínica Las Condes — Santiago, Chile (enrolling)
- Clínica San Carlos de Apoquindo — Santiago, Chile (enrolling)
- Clínica Santa Maria — Santiago, Chile (enrolling)
- Clínica Universidad de los Andes — Santiago, Chile (enrolling)
- Complejo Asistencial Dr. Sótero del Rio — Santiago, Chile (enrolling)
- Hospital Barros Luco — Santiago, Chile (enrolling)
- Hospital Clínico UC Christus — Santiago, Chile (enrolling)
- Hospital Clínico Universidad de Chile — Santiago, Chile (enrolling)
- Hospital Del Salvador Providencia — Santiago, Chile (enrolling)
- Hospital Dra. Eloisa Diaz — Santiago, Chile (enrolling)
Full record on ClinicalTrials.gov
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