Plain-English translation of NCT06814340 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
The CALMDOWN trial is testing a new approach to breathing support for patients with the most severe form of acute respiratory distress syndrome (ARDS) — a life-threatening condition where the lungs cannot deliver enough oxygen to the body. Patients in this trial are already on extracorporeal membrane oxygenation (ECMO), a machine that does the work of the heart and lungs while they heal. The study compares two strategies: one group will receive a gentler, 'near-sleep' style of breathing support for the first three days, while the other group receives the standard protective breathing support currently used.
Severe ARDS is extremely dangerous, and even with life support machines, many patients do not survive or recover their lung function. Doctors believe that gentler breathing support early on might reduce the damage that breathing tubes and ventilators can cause to already-injured lungs, potentially helping patients recover faster and live longer.
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If you join this trial, you will be randomly assigned to one of two breathing support strategies while you are on the ECMO machine. One group receives very gentle, minimal breathing support for the first three days, while the other group receives the standard protective breathing approach. Your doctors will monitor your oxygen levels, breathing, and overall condition closely. The study tracks how long you stay on the ECMO machine and your survival status through day 60, with follow-up at a hospital in Paris.
AI-generated summary from trial data · Aug 19, 2026 · Not medical advice
France