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Intensive Care Med. 2019 Feb 21. doi: 10.1007/s00134-019-05567-4. [Epub ahead of print]

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

Author information

1
Institute of Cardio-metabolism and Nutrition, and Service de médecine intensive-réanimation, Institut de Cardiologie, APHP Hôpital Pitié-Salpêtrière, Sorbonne Université, INSERM, UMRS_1166-ICAN, Paris, France.
2
Città della Salute e della Scienza di Torino, Department of Anesthesia and Intensive Care Medicine, University of Turin, Turin, Italy.
3
Keenan Research Center of the Li Ka Shing Knowledge Institute of St. Michael's Hospital, Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
4
Alma Mater Studiorum - Università di Bologna, Dipartimento di Scienze Mediche e Chirurgiche, Anesthesia and Intensive Care Medicine, Policlinico di Sant'Orsola, Via Massarenti, 9, 40138, Bologna, Italy. m.ranieri@unibo.it.

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

PMID:
30790030
DOI:
10.1007/s00134-019-05567-4

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