Actively Recruiting
Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respiratory Distress syndrome - CALMDOWN
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13
280
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of early near apneic ventilation compared to usual ultra-protective lung ventilation in patients with severe acute respiratory distress syndrome (ARDS) who are supported by venovenous extracorporeal membrane oxygenation (ECMO). The trial, named CALMDOWN, is a prospective, open-label, multicenter, randomized controlled study aiming to investigate whether early apneic ventilation can help reduce ventilator-induced lung injury, ECMO duration, and mortality by day 60 in this critically ill population. Participants are randomly assigned to one of two groups: one group receives near apneic ventilation during the first 3 days of ECMO using BIPAP/APRV or pressure-controlled ventilation with specific settings to maintain airway pressure and minimize ventilation rate. Neuromuscular blockade and sedation may be used as needed. After 3 days, apneic ventilation may continue or switch to ultra-protective lung ventilation at the physician's discretion. The other group receives standard ultra-protective lung ventilation throughout ECMO support with defined ventilator settings. Prone positioning is allowed in both groups based on physician judgment. During the study, participants will be monitored closely for outcomes including mortality at day 60, need for lung transplantation, persistence of ECMO support, and days alive without ECMO from day 0 to day 60. Additional assessments cover mortality and other clinical outcomes up to day 90, duration of ventilation, ICU stay, hospital stay, and complications such as pneumonia, pneumothorax, and right ventricular function. The trial is sponsored by Assistance Publique - Hôpitaux de Paris and runs until May 2030.
CONDITIONS
Brief 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 emergency inclusion without consent if necessary, with consent sought as soon as possible
- Registration with French Social Security (except AME)
You will not qualify if you...
- Age under 18 years
- Pregnancy or breastfeeding
- VV-ECMO initiated more than 48 hours (maximum tolerance +2 hours) before
- Cardiac arrest with no flow time over 10 minutes before ECMO within 48 hours prior to inclusion
- Irreversible neurological pathology
- End-stage chronic lung disease
- Contraindications for high PEEP such as untreated pneumothorax or barotrauma
- Irreversible ARDS with no hope for lung function recovery
- Patient moribund at randomization with SAPS II score over 90
- Liver cirrhosis Child B or C
- Lung transplantation
- Burns on more than 20% of the body surface
- Participation in another interventional study with similar primary endpoints or within exclusion period after previous study
- Individuals under guardianship or permanently legally incompetent adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 days from randomization
Participants receive venovenous extracorporeal membrane oxygenation (ECMO) with either near apneic ventilation during the first 3 days or ultra-protective lung ventilation until ECMO weaning. Ventilation settings and use of prone positioning are managed at the physician's discretion.
Daily assessments during ECMO treatment
Duration - Up to 90 days from randomization
Participants are monitored for clinical outcomes including survival, need for lung transplantation, duration of ECMO support, and lung function recovery up to 90 days after treatment initiation.
Regular follow-up visits up to Day 90
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
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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