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Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position in ARDS

RecruitingNAAges 18 Years - anyAllPontificia Universidad Catolica de Chile
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In plain words

What the trial is, and whether it could suit you

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 prolong

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Endotracheal intubation and mechanical ventilation for less than 72 hours * Moderate-severe ARDS defined as: 1. Within 1 week of a known clinical insult or new or worsening respiratory symptoms 2. Bilateral infiltrates not fully explained by effusions, lobar/lung collapse, or nodules 3. Respiratory failure not fully explained by cardiac failure or fluid overload 4. 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 Exclusion Criteria: * 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
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What it tests

  • Daily prone position sessions
  • Prolonged prone position sessions
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Where

38 sites
Hospital Britanico
Buenos Aires, Argentina
Sanatorio Güemes
Buenos Aires, Argentina
Sanatorio Mitre
Buenos Aires, Argentina
Hospital San Martin de la Plata, Argentina
La Plata, Argentina
Hospital Vera Barros
La Rioja, Argentina
Hospital Privado de comunidad
Mar del Plata, Argentina
Hospital Leonardo Guzmán
Antofagasta, Chile
Hospital Clínico Herminda Martín
Chillan, Chile

…and 30 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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