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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 3, 2025

Keywords

ClinConnect Summary

The CALMDOWN trial is a clinical study looking at a new approach for patients with severe Acute Respiratory Distress Syndrome (ARDS) who are on a special treatment called venovenous ECMO, which helps support breathing. This trial aims to see if a method called early apneic ventilation, which involves reducing breathing assistance temporarily, can help protect the lungs better and possibly lead to shorter time on ECMO and lower chances of death after 60 days.

To participate in this trial, patients must be adults aged 18 or older who have severe ARDS and have started ECMO support within the last 48 hours. They will need consent from a close family member if they cannot provide it themselves. Participants will be randomly assigned to either the new ventilation approach or standard care. The study is currently recruiting, and it’s important for potential participants to know that there are certain health conditions that would exclude them from joining, such as serious heart or lung issues, being pregnant, or having irreversible brain problems. This trial aims to find better ways to treat a serious condition, and every participant's contribution could lead to important discoveries.

Gender

ALL

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. 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 or being in the exclusion period at the end of a previous study, expect DRESSING-ECMO trial, which evaluates the use of sterile adhesive transparent dressings impregnated with Chlorhexidine gluconate on the cumulative incidence of ECMO cannula-related infection episodes.
• • 14. Individuals under guardianship, or permanently legally incompetent adults