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ClinicalTrials.gov ID

NCT06814340

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

280Estimated

Last Update Posted

Apr 13, 2026Actual

Start Date

May 6, 2025Actual

Primary Completion Date

May 6, 2029Estimated

Completion Date

May 6, 2030Estimated

Official Title

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

Brief 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.

• Acute Respiratory Distress Syndrome
• Extracorporeal Membrane Oxygenation Complication

• ECMO + near apneic ventilation
• ECMO + ultra-protective lung ventilation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

francois.barbier@chu-orleans.fr+33 2 38 22 99 39

emmanuelle.mercier@univ-tours.fr+33 2 47 47 38 55