RecruitingNot ApplicableNCT06854627

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

Effect of Continuous Prolonged Prone Position Versus Intermittent Daily Prone Position on Mortality in ARDS Patients: A Multicenter Randomized Controlled Trial

Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

780 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Respiratory Distress Syndrome

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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

Exclusion Criteria5

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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Interventions

PROCEDUREDaily prone position sessions

Prone 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.

PROCEDUREProlonged prone position sessions

Prone 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.