"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"

Recruiting now · Phase 3

Conditions studied: Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation Complication

In brief

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.

Key facts

Study ID

NCT06814340

Run by

Assistance Publique - Hôpitaux de Paris

People needed

280

Starts

2025-05-06

Expected to finish

2030-05-06

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
• Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
• French Social security registration (except AME)

You may not qualify if…

• Age < 18
• Pregnancy or breastfeeding
• Initiation of VV-ECMO > 48 h (maximum tolerance : +2h)
• Cardiac arrest with cumulated no flow time \&amp;gt;10 minutes before ECMO (within 48 hours prior to inclusion)
• Irreversible neurological pathology
• End-stage chronic lung disease
• Contraindications for high PEEP level: untreated pneumothorax, barotrauma
• Irreversible ARDS with no hope for lung function recovery
• Patient moribund on the day of randomization, SAPS II \&amp;gt;90
• Liver cirrhosis (Child B or C)
• Lung transplantation
• Burns on more than 20 % of the body surface
• Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study
• Individuals under guardianship, or permanently legally incompetent adults

Where it is running

• Avicenne Hospital — Bobigny, France (enrolling)
• Haut Levèque Hospital - CHU Bordeaux — Bordeaux, France (enrolling)
• Henri Mondor Hospital — Créteil, France (enrolling)
• Croix-Rousse Hospital - HCL — Lyon, France (enrolling)
• North Hospital - APHM — Marseille, France (enrolling)
• Mercy Hospital - CHR Metz — Metz, France (enrolling)
• Brabois Hospital - CHRU Nancy — Nancy, France (enrolling)
• CHU Orléans — Orléans, France (enrolling)
• Pitié-Salpêtrière Hospital — Paris, France (enrolling)
• Pontchaillou Hospital - CHU Rennes — Rennes, France (enrolling)
• CHU Tours — Tours, France (enrolling)

Full record on ClinicalTrials.gov

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