TY - JOUR
T1 - Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome
T2 - the SUPERNOVA study
AU - Combes, Alain
AU - Fanelli, Vito
AU - Pham, Tai
AU - Ranieri, V. Marco
AU - Goligher, Ewan C.
AU - Brodie, Daniel
AU - Pesenti, Antonio
AU - Beale, Richard
AU - Brochard, Laurent
AU - Chiche, Jean Daniel
AU - Fan, Eddy
AU - de Backer, Daniel
AU - Francois, Guy
AU - Ferguson, Niall
AU - Laffey, John
AU - Mercat, Alain
AU - Mc Auley, Daniel F.
AU - Müller, Thomas
AU - Quintel, Michael
AU - Vincent, Jean Louis
AU - Taccone, Fabio Silvio
AU - Peperstraete, Harlinde
AU - Morimont, Philippe
AU - Schmidt, Matthieu
AU - Levy, Bruno
AU - Diehl, Jean Luc
AU - Guervilly, Christophe
AU - Capelier, Gilles
AU - Vieillard-Baron, Antoine
AU - Messika, Jonathan
AU - Karagiannidis, Christian
AU - Moerer, Onnen
AU - Urbino, Rosario
AU - Antonelli, Massimo
AU - Mojoli, Francesco
AU - Alessandri, Francesco
AU - Grasselli, Giacomo
AU - Donker, Dirk
AU - Ferrer, Ricard
AU - Slutsky, Jordi Mancebo Arthur S.
AU - On behalf of the European Society of Intensive Care Medicine Trials Group and the “Strategy of Ultra-Protective lung ventilation with Extracorporeal CO2 Removal for New-Onset moderate to severe ARDS” (SUPERNOVA) investigators
N1 - Funding Information:
The trial was made possible thanks to an unrestricted grant from Alung Technologies Inc, Maquet (Getinge Group), and Novalung (Xenios now part of Fresenius Medical). They supported the costs of the data monitoring and site visits, the insurance fees, the supply of the equipment and materials, the shipments and the fees per patient. The grants from the companies amounted to €171,000 and were made available to the European Society of Intensive Care Medicine that supported the costs of the development and running of the eCRF platform, the IT infrastructure, and the administrative costs related to legal matters and contracting (insurance contracts, data use agreements, and hospital contracts). Members of the Data and Safety Monitoring Board: Jukka Takala, Chair (University Hospital Bern, Switzerland); Lluis Blanch Torra (Institut Universitari Fundació Parc Taulí-Universitat Autònoma de Barcelona, Spain); Christian Mélot (Erasme University Hospital, Brussel, Belgium) Investigators of the SUPERNOVA trial: Belgium: Jacques Creteur, Alexandre Brasseur (Erasme Hospital, Brussel); Daniel de Backer (CHIREC Hospitals, Brussel); Eric Hoste, Filip de Somer, Luc de Crop (Ghent University Hospital); Bernard Lambermont (University Hospital Liège). Canada: Martin Dres, Orla Smith (St. Michael’s Hospital, Toronto). France: Nicolas Brechot (Hôpital Pitié-Salpêtrière, Paris); Caroline Fritz, Antoine Kimmoun (Centre Hospitalier Universitaire de Nancy); Nadia Aissaoui, Emmanuel Guerot (Hôpital Européen Georges Pompidou, Paris Hôpital Nord); Laurent Papazian, Jean-Marie Forel (AP-HM Hopital Nord Marseille); Francois Belocncle, Marc Pierrot (Centre Hospitalier Universitaire Angers); Lucie Vet-toretti, Hadrien Winiszewski (Centre Hospitalier Universitaire de Besançon); Xavier Repesse, Cyril Charron (Hopital Ambroise Paré, Paris); Didier Dreyfuss, Stephane Gaudry (Hôpital Louis Mourier, Paris).
Publisher Copyright:
© 2019, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - Purpose: We assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (VT4 mL/kg and PPLAT≤25cmH2O) in patients with moderate acute respiratory distress syndrome (ARDS).Methods: Prospective multicenter international phase 2 study. Primary endpoint was the proportion of patients achieving ultra-protective ventilation with PaCO2 not increasing more than 20% from baseline, and arterial pH>7.30. Severe adverse events (SAE) and ECCO2R-related adverse events (ECCO2 R-AE) were reported to an independent data and safety monitoring board. We used lower CO2 extraction and higher CO2 extraction devices (membrane lung cross-sectional area 0.59 vs. 1.30 m 2 ; flow 300–500 mL/min vs. 800–1000 mL/min, respectively).Results: Ninety-five patients were enrolled. The proportion of patients who achieved ultra-protective settings by 8 h and 24 h was 78% (74 out of 95 patients; 95% confidence interval 68–89%) and 82% (78 out of 95 patients; 95% confidence interval 76–88%), respectively. ECCO2R was maintained for 5 [3–8] days. Six SAEs were reported; two of them were attributed to ECCO 2 R (brain hemorrhage and pneumothorax). ECCO2R-AEs were reported in 39% of the patients. A total of 69 patients (73%) were alive at day 28. Fifty-nine patients (62%) were alive at hospital discharge.Conclusions: Use of ECCO2 R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms.Clinicaltrials.gov: NCT02282657.
AB - Purpose: We assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (VT4 mL/kg and PPLAT≤25cmH2O) in patients with moderate acute respiratory distress syndrome (ARDS).Methods: Prospective multicenter international phase 2 study. Primary endpoint was the proportion of patients achieving ultra-protective ventilation with PaCO2 not increasing more than 20% from baseline, and arterial pH>7.30. Severe adverse events (SAE) and ECCO2R-related adverse events (ECCO2 R-AE) were reported to an independent data and safety monitoring board. We used lower CO2 extraction and higher CO2 extraction devices (membrane lung cross-sectional area 0.59 vs. 1.30 m 2 ; flow 300–500 mL/min vs. 800–1000 mL/min, respectively).Results: Ninety-five patients were enrolled. The proportion of patients who achieved ultra-protective settings by 8 h and 24 h was 78% (74 out of 95 patients; 95% confidence interval 68–89%) and 82% (78 out of 95 patients; 95% confidence interval 76–88%), respectively. ECCO2R was maintained for 5 [3–8] days. Six SAEs were reported; two of them were attributed to ECCO 2 R (brain hemorrhage and pneumothorax). ECCO2R-AEs were reported in 39% of the patients. A total of 69 patients (73%) were alive at day 28. Fifty-nine patients (62%) were alive at hospital discharge.Conclusions: Use of ECCO2 R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms.Clinicaltrials.gov: NCT02282657.
KW - Acute respiratory distress syndrome
KW - Extracorporeal carbon dioxide removal
KW - Mechanical ventilation
KW - Ventilator-induced lung injury
KW - n/a OA procedure
UR - http://www.scopus.com/inward/record.url?scp=85064889576&partnerID=8YFLogxK
U2 - 10.1007/s00134-019-05567-4
DO - 10.1007/s00134-019-05567-4
M3 - Article
C2 - 30790030
AN - SCOPUS:85064889576
SN - 0342-4642
VL - 45
SP - 592
EP - 600
JO - Intensive care medicine
JF - Intensive care medicine
IS - 5
ER -