Actively Recruiting
"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13
280
Participants Needed
11
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support within 48 hours (maximum tolerance: +2 hours) before inclusion
- Informed consent obtained from a close relative or surrogate, or randomization allowed without consent if patient unable and surrogate unavailable, with consent sought as soon as possible
- Registered with French Social Security (except AME)
You will not qualify if you...
- Age under 18 years
- Pregnancy or breastfeeding
- Initiation of VV-ECMO more than 48 hours before inclusion (maximum tolerance: +2 hours)
- Cardiac arrest with cumulative no flow time greater than 10 minutes before ECMO within 48 hours prior to inclusion
- Irreversible neurological pathology
- End-stage chronic lung disease
- Contraindications for high PEEP level such as untreated pneumothorax or barotrauma
- Irreversible ARDS with no hope for lung function recovery
- Patient moribund on day of randomization with SAPS II score greater than 90
- Liver cirrhosis classified as Child B or C
- Lung transplantation
- Burns covering more than 20% of body surface area
- Participation in another interventional study with similar primary endpoints or within exclusion period after such study
- Individuals under guardianship or permanently legally incompetent adults
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Avicenne Hospital
Bobigny, France
Actively Recruiting
2
Haut Levèque Hospital - CHU Bordeaux
Bordeaux, France
Actively Recruiting
3
Henri Mondor Hospital
Créteil, France
Actively Recruiting
4
Croix-Rousse Hospital - HCL
Lyon, France
Actively Recruiting
5
North Hospital - APHM
Marseille, France
Actively Recruiting
6
Mercy Hospital - CHR Metz
Metz, France
Actively Recruiting
7
Brabois Hospital - CHRU Nancy
Nancy, France
Actively Recruiting
8
CHU Orléans
Orléans, France
Actively Recruiting
9
Pitié-Salpêtrière Hospital
Paris, France
Actively Recruiting
10
Pontchaillou Hospital - CHU Rennes
Rennes, France
Actively Recruiting
11
CHU Tours
Tours, France
Actively Recruiting
Research Team
M
Matthieu SCHMIDT, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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