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

Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to help patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) who are on a ventilator. Specifically, the researchers want to find out if keeping patients in the prone position (lying on their stomachs) for more than 48 hours (called prolonged prone position) is better for survival compared to shorter sessions of 16 to 24 hours (called intermittent prone position). They will also check if there are any safety issues with the prolonged method compared to the shorter one.

To be part of this study, participants need to be adults aged 18 and older who have been on a ventilator for less than 72 hours and have been diagnosed with moderate to severe ARDS. If eligible, participants will receive prone positioning either for a longer stretch or in daily sessions during their first week of treatment. They will be monitored for up to 90 days to see how they are doing. This research is important as it aims to improve treatment options for patients facing serious breathing challenges.

Gender

ALL

Eligibility criteria

• 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