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

RecruitingPhase 3Ages 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion. 2. 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. 3. French Social security registration (except AME) Exclusion Criteria: 1. Age \< 18 2. Pregnancy or breastfeeding 3. Initiation of VV-ECMO \> 48 h (maximum tolerance : +2h) 4. Cardiac arrest with cumulated no flow time \&amp;gt;10 minutes before ECMO (within 48 hours prior to inclusion) 5. Irreversible neurological pathology 6. End-stage chronic lung disease 7. Contraindications for high PEEP level: untreated pneumothorax, barotrauma 8. Irreversible ARDS with no hope for lung function recovery 9. Patient moribund on the day of randomization, SAPS II \&amp;gt;90 10. Liver cirrhosis (Child B or C) 11. Lung transplantation 12. Burns on more than 20 % of the body surface 13. 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 14. Individuals under guardianship, or permanently legally incompetent adults
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What it tests

  • ECMO + near apneic ventilation
  • ECMO + ultra-protective lung ventilation
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Where

11 sites
Avicenne Hospital
Bobigny, France
Haut Levèque Hospital - CHU Bordeaux
Bordeaux, France
Henri Mondor Hospital
Créteil, France
Croix-Rousse Hospital - HCL
Lyon, France
North Hospital - APHM
Marseille, France
Mercy Hospital - CHR Metz
Metz, France
Brabois Hospital - CHRU Nancy
Nancy, France
CHU Orléans
Orléans, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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