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21.02.2019 | Seven-Day Profile Publication

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

verfasst von: Alain Combes, Vito Fanelli, Tai Pham, V. Marco Ranieri, 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

Erschienen in: Intensive Care Medicine | Ausgabe 5/2019

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Abstract

Purpose

We assessed feasibility and safety of extracorporeal carbon dioxide removal (ECCO₂R) to facilitate ultra-protective ventilation (V_T 4 mL/kg and P_PLAT ≤ 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

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Blood flow with the iLA activve (Novalung) and Cardiohelp^® HLS 5.0 (Getinge) can range between 0.5 and 4.5 L/min, but was limited by study protocol to 800–1000 mL/min.

The study protocol (see online supplement) originally said: “aPTT ratio is maintained at 1.5–2.0 × baseline”. However, the case report form did not ask for aPTT ratio but for absolute aPTT values (see online supplement). This inconsistency was communicated to investigators at the beginning of the study and readers at the moment of publication. For the sake of transparency, we left unchanged study protocol and statement on ClinicalTrials.Gov.

On ClinicalTrials.Gov (NCT02282657) and in the study protocol (see online supplement) the primary endpoint is formalized as: “achievement of V_T reduction to 4 mL/kg while maintaining pH and PaCO₂ to ± 20% of baseline values obtained at V_T of 6 mL/kg”. This formulation contains an obvious error that is the phrase “maintaining pH to ± 20% of baseline values”. Such variability of pH in fact does not make sense, allowing pH values ranging between 5.92 and 8.88. To avoid confusion and bias we (a) clarified the issue on the protocol with investigators at the beginning of the study; (b) left unchanged the statement on ClinicalTrials.Gov informing the readers about the mistake at the moment of publication.

Slutsky AS, Ranieri VM (2013) Ventilator-induced lung injury. N Engl J Med 369:2126–2136CrossRefPubMed

Dreyfuss D, Saumon G (1998) From ventilator-induced lung injury to multiple organ dysfunction? Intensive Care Med 24:102–104CrossRefPubMed

The Acute Respiratory Distress Syndrome network (2000) Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med 342:1301–1308CrossRef

Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM (2007) Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med 175:160–166CrossRefPubMed

Bellani G, Guerra L, Musch G, Zanella A, Patroniti N, Mauri T, Messa C, Pesenti A (2011) Lung regional metabolic activity and gas volume changes induced by tidal ventilation in patients with acute lung injury. Am J Respir Crit Care Med 183:1193–1199CrossRefPubMedPubMedCentral

Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM (2009) Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology 111:826–835CrossRefPubMed

Fanelli V, Costamagna A, Ranieri VM (2014) Extracorporeal support for severe acute respiratory failure. Semin Respir Crit Care Med 35:519–527CrossRefPubMed

Fanelli V, Ranieri MV, Mancebo J, Moerer O, Quintel M, Morley S, Moran I, Parrilla F, Costamagna A, Gaudiosi M, Combes A (2016) Feasibility and safety of low-flow extracorporeal carbon dioxide removal to facilitate ultra-protective ventilation in patients with moderate acute respiratory distress syndrome. Crit Care 20:36–43CrossRefPubMedPubMedCentral

Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A (2018) Feasibility and safety of low-flow extracorporeal CO₂ removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care 22:122–130CrossRefPubMedPubMedCentral

10.

Winiszewski H, Aptel F, Belon F, Belin N, Chaignat C, Patry C, Clermont C, David E, Navellou JC, Labro G, Piton G, Capellier G (2018) Daily use of extracorporeal CO2 removal in a critical care unit: indications and results. J Intensive Care 6:36–44CrossRefPubMedPubMedCentral

11.

Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS (2013) Lower tidal volume strategy (approximately 3 ml/kg) combined with extracorporeal CO2 removal versus ‘conventional’ protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med 39:847–856CrossRefPubMedPubMedCentral

12.

Grasso S, Stripoli T, Mazzone P, Pezzuto M, Lacitignola L, Centonze P, Guarracino A, Esposito C, Herrmann P, Quintel M, Trerotoli P, Bruno F, Crovace A, Staffieri F (2014) Low respiratory rate plus minimally invasive extracorporeal CO₂ removal decreases systemic and pulmonary inflammatory mediators in experimental acute respiratory distress syndrome. Crit Care Med 42:e451–460CrossRefPubMed

13.

Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG (2015) Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med 372:747–755CrossRefPubMed

14.

Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M (2016) Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med 42:1567–1575CrossRefPubMed

15.

Deniau B, Ricard JD, Messika J, Dreyfuss D, Gaudry S (2016) Use of extracorporeal carbon dioxide removal (ECCO2R) in 239 intensive care units: results from a French national survey. Intensive Care Med 42:624–625CrossRefPubMed

16.

Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS (2012) Acute respiratory distress syndrome: the Berlin definition. JAMA 307:2526–2533PubMed

17.

Mercat A, Richard JC, Vielle B, Jaber S, Osman D, Diehl JL, Lefrant JY, Prat G, Richecoeur J, Nieszkowska A, Gervais C, Baudot J, Bouadma L, Brochard L, Expiratory Pressure Study Group (2008) Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA 299:646–655CrossRefPubMed

18.

Morelli A, Del Sorbo L, Pesenti A, Ranieri VM, Fan E (2017) Extracorporeal carbon dioxide removal (ECCO2R) in patients with acute respiratory failure. Intensive Care Med 43:519–530CrossRefPubMed

19.

Retamal J, Libuy J, Jimenez M, Delgado M, Besa C, Bugedo G, Bruhn A (2013) Preliminary study of ventilation with 4 ml/kg tidal volume in acute respiratory distress syndrome: feasibility and effects on cyclic recruitment—derecruitment and hyperinflation. Crit Care 17:R16–R22CrossRefPubMedPubMedCentral

20.

Curley G, Laffey JG, Kavanagh BP (2010) Bench-to-bedside review: carbon dioxide. Crit Care 14:220–227CrossRefPubMedPubMedCentral

21.

Masterson C, Otulakowski G, Kavanagh BP (2015) Hypercapnia: clinical relevance and mechanisms of action. Curr Opin Crit Care 21:7–12CrossRefPubMed

22.

Nin N, Muriel A, Penuelas O, Brochard L, Lorente JA, Ferguson ND, Raymondos K, Rios F, Violi DA, Thille AW, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Soto L, D’Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A, Sznajder JI, Esteban A, VENTILA Group (2017) Severe hypercapnia and outcome of mechanically ventilated patients with moderate or severe acute respiratory distress syndrome. Intensive Care Med 43:200–208CrossRefPubMedPubMedCentral

23.

Sahetya SK, Mancebo J, Brower RG (2017) 50 years of research in ARDS. Vt selection in the acute respiratory distress syndrome. Am J Respir Crit Care Med 196:1519–1525CrossRefPubMedPubMedCentral

24.

Duscio E, Cipulli F, Vasques F, Collino F, Rapetti F, Romitti F, Behnemann T, Niewenhuys J, Tonetti T, Pasticci I, Vassalli F, Reupke V, Moerer O, Quintel M, Gattinoni L (2019) Extracorporeal CO₂ removal: the minimally invasive approach, theory, and practice. Crit Care Med 47:33–40CrossRefPubMed

25.

Goligher EC, Amato MBP, Slutsky AS (2017) applying precision medicine to trial design using physiology. Extracorporeal CO₂ removal for acute respiratory distress syndrome. Am J Respir Crit Care Med 196:558–568CrossRefPubMed

Titel: Feasibility and safety of extracorporeal CO2 removal to enhance protective ventilation in acute respiratory distress syndrome: the SUPERNOVA study
verfasst von: Alain Combes
Vito Fanelli
Tai Pham
V. Marco Ranieri
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
Publikationsdatum: 21.02.2019
Verlag: Springer Berlin Heidelberg
Erschienen in: Intensive Care Medicine / Ausgabe 5/2019
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-019-05567-4

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

Abstract

Purpose

Methods

Results

Conclusions

Clinicaltrials.gov

Neu im Fachgebiet AINS

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Springer Medizin

Abstract

Purpose

Methods

Results

Conclusions

Clinicaltrials.gov

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