Purpose: We assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO 2 R) to facilitate ultra-protective ventilation (V T 4 mL/kg and P PLAT ≤ 25 cmH 2 O) 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 PaCO 2 not increasing more than 20% from baseline, and arterial pH > 7.30. Severe adverse events (SAE) and ECCO 2 R-related adverse events (ECCO 2 R-AE) were reported to an independent data and safety monitoring board. We used lower CO 2 extraction and higher CO 2 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. ECCO 2 R was maintained for 5 [3–8] days. Six SAEs were reported; two of them were attributed to ECCO 2 R (brain hemorrhage and pneumothorax). ECCO 2 R-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 ECCO 2 R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms. Clinicaltrials.gov: NCT02282657.
Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study / Combes, A.; Fanelli, V.; Pham, T.; Ranieri, V. M.; Goligher, E. C.; Brodie, D.; Pesenti, A.; Beale, R.; Brochard, L.; Chiche, J. -D.; Fan, E.; de Backer, D.; Francois, G.; Ferguson, N.; Laffey, J.; Mercat, A.; Mc Auley, D. F.; Muller, T.; Quintel, M.; Vincent, J. -L.; Taccone, F. S.; Peperstraete, H.; Morimont, P.; Schmidt, M.; Levy, B.; Diehl, J. -L.; Guervilly, C.; Capelier, G.; Vieillard-Baron, A.; Messika, J.; Karagiannidis, C.; Moerer, O.; Urbino, R.; Antonelli, M.; Mojoli, F.; Alessandri, F.; Grasselli, G.; Donker, D.; Ferrer, R.; Slutsky, J. M. A. S.. - In: INTENSIVE CARE MEDICINE. - ISSN 0342-4642. - 45:5(2019), pp. 592-600. [10.1007/s00134-019-05567-4]
Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study
Ranieri V. M.
;Pesenti A.;Alessandri F.;Ferrer R.;
2019
Abstract
Purpose: We assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO 2 R) to facilitate ultra-protective ventilation (V T 4 mL/kg and P PLAT ≤ 25 cmH 2 O) 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 PaCO 2 not increasing more than 20% from baseline, and arterial pH > 7.30. Severe adverse events (SAE) and ECCO 2 R-related adverse events (ECCO 2 R-AE) were reported to an independent data and safety monitoring board. We used lower CO 2 extraction and higher CO 2 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. ECCO 2 R was maintained for 5 [3–8] days. Six SAEs were reported; two of them were attributed to ECCO 2 R (brain hemorrhage and pneumothorax). ECCO 2 R-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 ECCO 2 R to facilitate ultra-protective ventilation was feasible. A randomized clinical trial is required to assess the overall benefits and harms. Clinicaltrials.gov: NCT02282657.| File | Dimensione | Formato | |
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