Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study

Alain Combes, Vito Fanelli, Tai Pham, V Marco Ranieri, 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, Ewan C Goligher, Daniel Brodie, Antonio Pesenti, Richard Beale, Laurent Brochard, Jean-Daniel Chiche, Eddy Fan, Daniel de Backer, Guy Francois, Niall Ferguson, John Laffey, Alain Mercat, Daniel F Mc Auley, Thomas Müller, Michael Quintel, Jean-Louis Vincent, Fabio Silvio Taccone, Harlinde Peperstraete, Philippe Morimont, Matthieu Schmidt, Bruno Levy, Jean-Luc Diehl, Christophe Guervilly, Gilles Capelier, Antoine Vieillard-Baron, Jonathan Messika, Christian Karagiannidis, Onnen Moerer, Rosario Urbino, Massimo Antonelli, Francesco Mojoli, Francesco Alessandri, Giacomo Grasselli, Dirk Donker, Ricard Ferrer, Jordi Mancebo Arthur S Slutsky, Alain Combes, Vito Fanelli, Tai Pham, V Marco Ranieri, 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, Ewan C Goligher, Daniel Brodie, Antonio Pesenti, Richard Beale, Laurent Brochard, Jean-Daniel Chiche, Eddy Fan, Daniel de Backer, Guy Francois, Niall Ferguson, John Laffey, Alain Mercat, Daniel F Mc Auley, Thomas Müller, Michael Quintel, Jean-Louis Vincent, Fabio Silvio Taccone, Harlinde Peperstraete, Philippe Morimont, Matthieu Schmidt, Bruno Levy, Jean-Luc Diehl, Christophe Guervilly, Gilles Capelier, Antoine Vieillard-Baron, Jonathan Messika, Christian Karagiannidis, Onnen Moerer, Rosario Urbino, Massimo Antonelli, Francesco Mojoli, Francesco Alessandri, Giacomo Grasselli, Dirk Donker, Ricard Ferrer, Jordi Mancebo Arthur S Slutsky

Abstract

Purpose: We assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (VT 4 mL/kg and PPLAT ≤ 25 cmH2O) 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 (ECCO2R-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 m2; 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 ECCO2R (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 ECCO2R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms. CLINICALTRIALS.GOV: NCT02282657.

Keywords: Acute respiratory distress syndrome; Extracorporeal carbon dioxide removal; Mechanical ventilation; Ventilator-induced lung injury.

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Source: PubMed

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