RecruitingPhase 3NCT06814340

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

280 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ECMO + near apneic ventilation and a medical device called ECMO + ultra-protective lung ventilation for people with acute respiratory distress syndrome and extracorporeal membrane oxygenation complication. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEECMO + near apneic ventilation

Near apneic ventilation will be use during the first 3 days of ECMO. Patients will be ventilated in BIPAP/APRV or pressure-controlled ventilation. PEEP will be set to maintain the same mean airway pressure obtained during the standardized ventilation period pre-randomization to prevent lung derecruitment (PEEP ≥15cmH2O). If BIPAP/APRV is used, an RR of 2-4/min will be set with high pressure set at 30cmH20 for 3 sec. If pressure-controlled ventilation is selected, a respiratory rate of two sigh breaths/min with 30 cmH2O plateau pressure will be applied. Each sigh breath will be of three seconds duration. Neuromuscular blockade and sedation could be used at the discretion of the attending physician. After 3 days on ECMO, apneic ventilation could be pursued (at the physician's discretion). If not, ultra-protective lung ventilation will be applied (i.e standard of care). Prone positioning on ECMO will be left to the physicians' discretion.

DEVICEECMO + ultra-protective lung ventilation

Ultra-protective lung ventilation will be used up to the ECMO weaning. This group will receive ultra-protective lung ventilation with BIPAP/APRV or VCV mode setting a PEEP \>10 cmH2O, ΔP 14-15 cmH2O, RR 15-20/min, Vt 3-4ml/kg and lowest FiO2 to maintain SpO2\>92%. The use of prone positioning during ECMO will be left at the physician's discretion.


Locations(11)

Avicenne Hospital

Bobigny, France

Haut Levèque Hospital - CHU Bordeaux

Bordeaux, France

Henri Mondor Hospital

Créteil, France

Croix-Rousse Hospital - HCL

Lyon, France

North Hospital - APHM

Marseille, France

Mercy Hospital - CHR Metz

Metz, France

Brabois Hospital - CHRU Nancy

Nancy, France

CHU Orléans

Orléans, France

Pitié-Salpêtrière Hospital

Paris, France

Pontchaillou Hospital - CHU Rennes

Rennes, France

CHU Tours

Tours, France

View Full Details on ClinicalTrials.gov

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NCT06814340


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