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NCT06814340: CALMDOWN
"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"
Phase 3 trial testing ECMO + near apneic ventilation in Acute Respiratory Distress Syndrome in 280 participants. Currently enrolling.
6 May 2029
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 280 |
| Start date | 6 May 2025 |
| Primary completion | 6 May 2029 |
| Estimated completion | 6 May 2030 |
| Sites | 11 locations across France |
Drugs / interventions tested
- ECMO + near apneic ventilation
- ECMO + ultra-protective lung ventilation
Conditions studied
- Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
- Extracorporeal Membrane Oxygenation Complication — all drugs for Extracorporeal Membrane Oxygenation Complication →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Acute Respiratory Distress Syndrome or Extracorporeal Membrane Oxygenation Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation). The study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO. Indeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06814340
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Respiratory Distress Syndrome
Currently open trials in the same condition.
- NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · recruiting
- NCT07289711 — Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter C · recruiting
- NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
- NCT06919484 — The Physiological Effect of RCexp on Ventilation/Perfusion Distribution · recruiting
- NCT07126964 — Extended Prone Positioning for Intubated ARDS · NA · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06814340 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06814340.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing