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"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme" - CALMDOWN
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Avicenne Hospital
Bobigny, France
Henri Mondor Hospital
Créteil, France
Pitié-Salpêtrière Hospital
Paris, France
Start Date
May 6, 2025
Primary Completion Date
May 6, 2029
Completion Date
May 6, 2030
Last Updated
July 24, 2025
280
ESTIMATED participants
ECMO + near apneic ventilation
DEVICE
ECMO + ultra-protective lung ventilation
DEVICE
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
NCT07450846
NCT07414056
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05440851