Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

NACompletedINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

December 8, 2011

Primary Completion Date

July 31, 2017

Study Completion Date

September 30, 2017

Conditions
Acute Respiratory Distress Syndrome (ARDS)
Interventions
DEVICE

ECMO (Quadrox®, Jostra®, Maquet®)

ECMO will be initiated as rapidly as possible by venovenous access. The material to be used consists of pre-heparinized cannulae and tubing, a centrifuge pump (CardioHelp®) and a heparinized membrane oxygenator (Quadrox®, Jostra®, Maquet®). To minimize the trauma induced by mechanical ventilation, the following ventilator settings will be used: volume-assist control mode, FiO2 30-60%, PEEP ≥10 cm H2O, VT lowered to obtain a plateau pressure \<25 cm H2O, respiration rate (RR) 10-30/minute or APRV mode with high pressure level \<25 cm H2O and low pressure level ≥10 cm H2O

OTHER

conventional care

Standard management of ARDS, according to the modalities applied by the 'maximal pulmonary recruitment' group in the EXPRESS trial (1): assist-controlled ventilatory mode, VT set at 6 ml/kg of ideal body weight and PEEP set so as not to exceed a plateau pressure of 28-30 cm H2O. In the case of refractory hypoxemia, the usual adjunctive therapeutics can be used: NO, prone position, HFO ventilation, almitrine infusion. A cross-over option to ECMO will be possible in the case of refractory hypoxemia defined as blood arterial saturation SaO2 \<80% for \>6 hours, despite mandatory use of recruitment maneuvers, and inhaled NO/prostacyclin and if technically possible a test of prone position, and only if the patient has no irreversible multiple organ failure and if the physician in charge of the patient believes that this could actually change the outcome

Trial Locations (1)

75013

Groupe Hospitalier Pitié Salpêtrière, Paris

Sponsors
All Listed Sponsors
collaborator

Maquet Cardiopulmonary GmbH

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01470703 - Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome | Biotech Hunter | Biotech Hunter