Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group : near apneic ventilation | Experimental | Patients will received near apneic ventilation during the first 3 days of ECMO. |
|
| Standard of care : ultra-protective lung ventilation | Active Comparator | Patients will receive ultra-protective lung ventilation as it uses on usual care on ECMO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECMO + near apneic ventilation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the application of early apneic ventilation on four components : mortality status at D60, need for lung transplantation at D60, persisting ECMO at D60, number of days alive between randomization and day 60 without ECMO | These components will be summarized in a composite, hierarchical outcome. Each patient will be compared with every other patient in the study and assigned a score (tie: 0, win: +1, loss: -1) for each pairwise comparison based on whom fared better. If one patient survived without lung transplantation or ECMO still ongoing at day 60 and the other did not, scores of +1 and -1 will be assigned, respectively. If both patients in the pairwise comparison survived without lung transplant or ECMO still ongoing at day 60, the assigned score will depend on which patient had more days free from ECMO: the patient with more days off ECMO will receive a score of +1, while the patient with fewer days will receive a score of -1. If both patients survived and had the same number of days off ECMO, or if both patients died or had a lung transplant, they will be both assigned a score of 0 for that pairwise comparison. | Day 0 to Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Efficacy of early apneic ventilation during VV-ECMO on mortality is defined as overall survival between inclusion and D60 | From Day 1 to Day 60 |
| Mortality | Efficacy of early apneic ventilation during VV-ECMO on mortality is defined as overall survival between inclusion and D90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthieu SCHMIDT, MD | Contact | 01 42 16 29 37 | matthieu.schmidt@aphp.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avicenne Hospital | Recruiting | Bobigny | France |
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
Researchers who provide a methodologically sound proposal.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ECMO + ultra-protective lung ventilation | Device | 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. |
|
| From Day 1 to Day 90 |
| Need for lung transplant | Efficacy of early apneic ventilation during VV-ECMO on the need for lung transplant is defined as lung transplant between inclusion and D60 | From Day 1 to Day 60 |
| Need for lung transplant | Efficacy of early apneic ventilation during VV-ECMO on the need for a lung transplant is defined as lung transplant between inclusion and D90 | From Day 1 to Day 90 |
| Duration of ECMO support | Defined as total duration with ECMO support between inclusion and D60 | From Day 1 to Day 60 |
| Duration of ECMO support | Defined as total duration with ECMO support between inclusion and D90 | From Day 1 to Day 90 |
| Duration of invasive mechanical ventilation | Defined as total duration of invasive mechanical ventilation between inclusion and D60 | From Day 1 to Day 60 |
| Duration of invasive mechanical ventilation | Defined as total duration of invasive mechanical ventilation between inclusion and D90 | From Day 1 to Day 90 |
| Duration of Intensive Care Unit | Defined as total duration spent in intensive care unit between inclusion and D60 | From Day 1 to Day 60 |
| Duration of Intensive Care Unit | Defined as total duration spent in intensive care unit between inclusion and D90 | From Day 1 to Day 90 |
| Hospital length of stay | Defined as total duration spent at the hospital between inclusion and D60 | From Day 1 to Day 60 |
| Hospital length of stay | Defined as total duration spent at the hospital between inclusion and D90 | From Day 1 to Day 90 |
| ECMO free days | Efficacy of early apneic ventilation during VV-ECMO on ECMO-free days is defined as the number of ECMO free-days between inclusion and D60 | From Day 1 to Day 60 |
| ECMO free days | Efficacy of early apneic ventilation during VV-ECMO on ECMO-free days is defined as number of ECMO free-days between inclusion and D90 | From Day 1 to Day 90 |
| Invasive mechanical ventilation free days | Efficacy of early apneic ventilation during VV-ECMO on invasive mecanical ventilation-free days between inclusion and D60 | From Day 1 to Day 60 |
| Invasive mechanical ventilation free days | Efficacy of early apneic ventilation during VV-ECMO on invasive mecanical ventilation-free days between inclusion and D90 | From Day 1 to Day 90 |
| Renal replacement therapy-free days | Efficacy of early apneic ventilation during VV-ECMO on renal function is defined as number of renal replacement therapy-free days between inclusion and D60 | From Day 1 to Day 60 |
| Renal replacement therapy-free days | Efficacy of early apneic ventilation during VV-ECMO on renal function is defined as renal replacement therapy-free days between inclusion and D90 | From Day 1 to Day 90 |
| Continuous neuromuscular blockade-free days | Efficacy of early apneic ventilation during VV-ECMO on continuous neuromuscular blockade is defined as number of continuous neuromuscular blockade-free days between inclusion and D60 | From Day 1 to Day 60 |
| Continuous neuromuscular blockade-free days | Efficacy of early apneic ventilation during VV-ECMO on continuous neuromuscular blockade is defined as number of continuous neuromuscular blockade-free days between inclusion and D90 | From Day 1 to Day 90 |
| Intervention side effects (ventilation-associated pneumonia) | Defined as the incidence of ventilation-associated pneumonia between inclusion and D14 | From Day 1 to Day D14 |
| Intervention side effets (need for inotropes or vasopressors) | Defined as the incidence of need for inotropes or vasopressors within 14 days on ECMO | From Day 1 to Day 14 |
| Intervention side effets (intravenous sedation consumption) | Defined as the incidence of intravenous sedation consumption during the first 14 days on ECMO | From Day 1 to Day 14 |
| Acute cor pulmonale | Defined as the incidence of acute cor pulmonale between inclusion and D60 | From Day 1 to Day 60 |
| Acute cor pulmonale | Defined as the incidence of acute cor pulmonale between inclusion and D90 | From Day 1 to Day 90 |
| Pneumothorax | Defined as the incidence of pneumothorax between inclusion and D60 | From Day 1 to Day 60 |
| Pneumothorax | Defined as the incidence of pneumothorax between inclusion and D90 | From Day 1 to Day 90 |
| Severe refractory hypoxemia on ECMO | Defined as the incidence of refractory severe hypoxemia between inclusion and D60 | From Day 1 to Day 60 |
| Severe refractory hypoxemia on ECMO | Defined as the incidence of refractory severe hypoxemia between inclusion and D90 | From Day 1 to Day 90 |
| Compliance of the respiratory system at D7 | Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D7 | From Day 1 to Day 7 |
| Compliance of the respiratory system at D10 | Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D10 | From Day 1 to Day 10 |
| Compliance of the respiratory system at D14 | Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D14 | From Day 1 to Day 14 |
| Compliance of the respiratory system at D28 | Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D28 | From Day 1 to Day 28 |
| Compliance of the respiratory system at D60 | Effect of near apneic ventilation on the improvement of the compliance of the respiratory system (ml/cmH2O) at D60 | From Day 1 to Day 60 |
| Right ventricular function at D3 | Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D3 on ECMO following randomization | From Day 1 to Day 3 |
| Right ventricular function at D7 | Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D7 on ECMO following randomization | From Day 1 to Day 7 |
| Right ventricular function at D14 | Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D14 on ECMO following randomization | From Day 1 to Day 14 |
| Right ventricular function at D28 | Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D28 on ECMO following randomization | From Day 1 to Day 28 |
| Right ventricular function at D60 | Effect of near apneic ventilation on right ventricular function evaluated by echocardiograohy (RV/LV diameter ratio) at D60 on ECMO following randomization | From Day 1 to Day 60 |
| Haut Levèque Hospital - CHU Bordeaux | Recruiting | Bordeaux | France |
|
| Henri Mondor Hospital | Recruiting | Créteil | France |
|
| Croix-Rousse Hospital - HCL | Recruiting | Lyon | France |
|
| North Hospital - APHM | Recruiting | Marseille | France |
|
| Mercy Hospital - CHR Metz | Recruiting | Metz | France |
|
| Brabois Hospital - CHRU Nancy | Recruiting | Nancy | France |
|
| CHU Orléans | Recruiting | Orléans | France |
|
| Pitié-Salpêtrière Hospital | Recruiting | Paris | France |
|
| Pontchaillou Hospital - CHU Rennes | Recruiting | Rennes | France |
|
| CHU Tours | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided