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

被引:180
作者
Combes, Alain [1 ,2 ]
Fanelli, Vito [3 ]
Pham, Tai [4 ]
Ranieri, V. Marco [5 ]
Goligher, Ewan C. [4 ]
Brodie, Daniel [6 ,7 ]
Pesenti, Antonio [8 ]
Beale, Richard [9 ]
Brochard, Laurent [4 ]
Chiche, Jean-Daniel [10 ]
Fan, Eddy [11 ]
de Backer, Daniel [12 ]
Francois, Guy [13 ]
Ferguson, Niall [11 ]
Laffey, John [14 ,15 ]
Mercat, Alain [16 ]
McAuley, Daniel F. [17 ,18 ]
Mueller, Thomas [19 ]
Quintel, Michael [20 ]
Vincent, Jean-Louis [21 ]
Taccone, Fabio Silvio [21 ]
Peperstraete, Harlinde [22 ]
Morimont, Philippe [23 ]
Schmidt, Matthieu [1 ,2 ]
Levy, Bruno [24 ,25 ]
Diehl, Jean-Luc [26 ]
Guervilly, Christophe [27 ]
Capelier, Gilles [28 ]
Vieillard-Baron, Antoine [29 ]
Messika, Jonathan [30 ]
Karagiannidis, Christian [31 ,32 ]
Moerer, Onnen [20 ]
Urbino, Rosario [3 ]
Antonelli, Massimo [33 ]
Mojoli, Francesco [34 ]
Alessandri, Francesco [35 ]
Grasselli, Giacomo [8 ]
Donker, Dirk [36 ]
Ferrer, Ricard [37 ]
Mancebo, Jordi [38 ]
Slutsky, Arthur S. [4 ]
机构
[1] Sorbonne Univ, Hop Pitie Salpetriere, AP HP, Inst Cardiometab & Nutr,INSERM,UMRS 1166,ICAN, Paris, France
[2] Sorbonne Univ, Hop Pitie Salpetriere, AP HP,ICAN, Serv Med Intens Reanimat,Inst Cardiol,INSERM,UMRS, Paris, France
[3] Univ Turin, Citta Salute & Sci Torino, Dept Anesthesia & Intens Care Med, Turin, Italy
[4] Univ Toronto, Keenan Res Ctr, Li Ka Shing Knowledge Inst, St Michaels Hosp,Interdept Div Crit Care Med, Toronto, ON, Canada
[5] Univ Bologna, Alma Mater Studiorum, Dipartimento Sci Med & Chirurg Anesthesia & Inten, Policlin St Orsola, Via Massarenti 9, I-40138 Bologna, Italy
[6] Columbia Univ, Coll Phys & Surg, Div Pulm Allergy & Crit Care Med, New York, NY USA
[7] New York Presbyterian Hosp, New York, NY USA
[8] Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Milan, Italy
[9] Guys & St Thomas NHS Fdn Trust, London, England
[10] Univ Paris 05, Hop Cochin, Paris, France
[11] Univ Toronto, Toronto Gen Hosp, Toronto, ON, Canada
[12] Univ Libre Bruxelles, Hop Braine Alleud Waterloo, Brussels, Belgium
[13] European Soc Intens Care Med, Brussels, Belgium
[14] Galway Univ Hosp, Galway, Ireland
[15] Natl Univ Ireland, Galway, Ireland
[16] Univ Angers, Ctr Hosp Univ, Angers, France
[17] Queens Univ Belfast, Ctr Expt Med, Belfast, Antrim, North Ireland
[18] Royal Victoria Hosp, Reg Intens Care Unit, Belfast, Antrim, North Ireland
[19] Univ Hosp Regensburg, Regensburg, Germany
[20] Univ Med Gottingen, Gottingen, Germany
[21] Univ Libre Bruxelles, Erasme Univ Hosp, Brussels, Belgium
[22] Ghent Univ Hosp, Ghent, Belgium
[23] Univ Hosp Liege, Liege, Belgium
[24] CHRU Nancy, Serv Reanimat Med Brabois, Pole Cardiomedicochirurg, INSERM,U1116,Fac Med, F-54511 Vandoeuvre Les Nancy, France
[25] Univ Lorraine, Nancy, France
[26] Hop Europeen Georges Pompidou, Paris, France
[27] Hop Nord Marseille, AP HM, Serv Med Intens Reanimat, Marseille, France
[28] Ctr Hosp Univ Besancon, Besancon, France
[29] Hop Ambroise Pare, Paris, France
[30] Hop Louis Mourier, Paris, France
[31] Kliniken Stadt Koln, Cologne, Germany
[32] Univ Witten Herdecke, Cologne, Germany
[33] Fdn Policlin Univ A Gemelli IRCCS, Rome, Italy
[34] Fdn IRCCS Policlin San Matteo, Pavia, Italy
[35] Policlin Umberto 1, Rome, Italy
[36] Univ Utrecht, Med Ctr, Univ Med Ctr, Utrecht, Netherlands
[37] Hosp Univ Vall dHebron, Barcelona, Spain
[38] Hosp Santa Creu & Sant Pau, Barcelona, Spain
关键词
Acute respiratory distress syndrome; Mechanical ventilation; Extracorporeal carbon dioxide removal; Ventilator-induced lung injury; LUNG INJURY; 6; ML/KG; HYPERCAPNIA; PRESSURE; ECCO2R;
D O I
10.1007/s00134-019-05567-4
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
PurposeWe assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO2R) to facilitate ultra-protective ventilation (V-T 4mL/kg and P(PLAT)25cmH(2)O) in patients with moderate acute respiratory distress syndrome (ARDS).MethodsProspective 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. 1.30m(2); flow 300-500mL/min vs. 800-1000mL/min, respectively).ResultsNinety-five patients were enrolled. The proportion of patients who achieved ultra-protective settings by 8h and 24h 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.ConclusionsUse of ECCO2R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms.Clinicaltrials.govNCT02282657
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收藏
页码:592 / 600
页数:9
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