Status:
RECRUITING
"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Respiratory Distress Syndrome
Extracorporeal Membrane Oxygenation Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 venti...
Eligibility Criteria
Inclusion
- 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.
- Social security registration (except AME)
Exclusion
- Age \< 18
- Pregnancy or breastfeeding
- Initiation of VV-ECMO \> 48 h (maximum tolerance : +2h)
- Cardiac arrest with cumulated no flow time \&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 \&gt;90
- Liver cirrhosis (Child B or C)
- Lung transplantation
- Burns on more than 20 % of the body surface
- Participation in another interventional study or being in the exclusion period at the end of a previous study, expect DRESSING-ECMO trial, which evaluates the use of sterile adhesive transparent dressings impregnated with Chlorhexidine gluconate on the cumulative incidence of ECMO cannula-related infection episodes.
- Individuals under guardianship, or permanently legally incompetent adults
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 6 2030
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06814340
Start Date
May 6 2025
End Date
May 6 2030
Last Update
July 24 2025
Active Locations (3)
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1
Avicenne Hospital
Bobigny, France
2
Henri Mondor Hospital
Créteil, France
3
Pitié-Salpêtrière Hospital
Paris, France