Using near apneic ventilation with ECMO for severe respiratory distress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CALMDOWN trial is a multicenter, open-label, controlled trial that aims to compare the effects of near apneic ventilation versus usual care in patients with severe acute respiratory distress syndrome (ARDS) who are on venovenous extracorporeal membrane oxygenation (VV-ECMO). The study hypothesizes that early implementation of near apneic ventilation can prevent ventilator-induced lung injury, potentially leading to reduced ECMO duration and lower mortality rates at Day 60. Patients will be randomized to receive either near apneic ventilation or ultra-protective lung ventilation while on ECMO support.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
2. 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.
3. French Social security registration (except AME)

Exclusion Criteria:

1. Age \< 18
2. Pregnancy or breastfeeding
3. Initiation of VV-ECMO \> 48 h (maximum tolerance : +2h)
4. Cardiac arrest with cumulated no flow time \&amp;gt;10 minutes before ECMO (within 48 hours prior to inclusion)
5. Irreversible neurological pathology
6. End-stage chronic lung disease
7. Contraindications for high PEEP level: untreated pneumothorax, barotrauma
8. Irreversible ARDS with no hope for lung function recovery
9. Patient moribund on the day of randomization, SAPS II \&amp;gt;90
10. Liver cirrhosis (Child B or C)
11. Lung transplantation
12. Burns on more than 20 % of the body surface
13. Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study
14. Individuals under guardianship, or permanently legally incompetent adults

Where it's running

• Avicenne Hospital
  Bobigny, France Recruiting
• Haut Levèque Hospital - CHU Bordeaux
  Bordeaux, France Recruiting
• Henri Mondor Hospital
  Créteil, France Recruiting
• Croix-Rousse Hospital - HCL
  Lyon, France Recruiting
• North Hospital - APHM
  Marseille, France Recruiting
• Mercy Hospital - CHR Metz
  Metz, France Recruiting

Study contacts

• Study coordinator: Matthieu SCHMIDT, MD
• Email: matthieu.schmidt@aphp.fr
• Phone: 01 42 16 29 37

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Full-Course ECMO Pathway for Moderate-to-Severe ARDS

  This study tests a standardized, full-course ECMO management pathway to see if it improves care for adults with moderate-to-severe ARDS treated with VV-ECMO in real-world Chinese centers.

  Recruiting at 15 sites Southeast University, China · Beijing and 38 other locations · NCT07726953

• Height measurement methods to guide ventilator settings in ARDS

  We’re testing whether more precise height measurements change how researchers set lung-protective tidal volumes in adults with ARDS who are on a ventilator.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07595926

• Corticosteroids for a hyperinflammatory state in critical illness

  This trial tests whether methylprednisolone helps improve organ function and survival in adults with sepsis or ARDS who show a hyperinflammatory profile.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07511582

• Right‑heart function and heart–lung interaction during ARDS with mechanical ventilation

  This project will follow adults with ARDS on mechanical ventilation to see how positive‑pressure breathing affects the right heart over time and how that relates to circulation.

  Recruiting Bicetre Hospital · Le Kremlin-Bicêtre · NCT07450846

• Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS

  This trial tests whether IV umbilical‑cord mesenchymal stem cells, alone or with secretome, help adults with severe ARDS recover lung function and reduce inflammation.

  Recruiting Phase 1/2 PT. Prodia Stem Cell Indonesia · Jakarta Pusat, DKI Jakarta · NCT07439848

• Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

  This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

  Recruiting Phase 1/2 Changchun Tuohua Pharmaceutical Co., Ltd. · Wuhan, Hubei · NCT07413978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.