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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Avicenne Hospital
RECRUITING
Bobigny
Henri Mondor Hospital
RECRUITING
Créteil
Pitié-Salpêtrière Hospital
RECRUITING
Paris
Contact Information
Primary
Matthieu SCHMIDT, MD
matthieu.schmidt@aphp.fr
01 42 16 29 37
Time Frame
Start Date: 2025-05-06
Estimated Completion Date: 2030-05-06
Participants
Target number of participants: 280
Treatments
Experimental: Intervention group : near apneic ventilation
Patients will received near apneic ventilation during the first 3 days of ECMO.
Active_comparator: Standard of care : ultra-protective lung ventilation
Patients will receive ultra-protective lung ventilation as it uses on usual care on ECMO.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov