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Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial

2019; Elsevier BV; Volume: 7; Issue: 10 Linguagem: Inglês

10.1016/s2213-2600(19)30138-9

2213-2619

Jean‐Michel Constantin, Matthieu Jabaudon, Jean‐Yves Lefrant, Samir Jaber, Jean‐Pierre Quenot, Olivier Langeron, Martine Ferrandière, Fabien Grelon, Philippe Séguin, Carole Ichaï, Benoît Veber, Bertrand Souweine, Thomas Uberti, Sigismond Lasocki, François Legay, Marc Léone, Nathanaël Eisenmann, Claire Dahyot‐Fizelier, Hervé Dupont, Karim Asehnoune, Achille Sossou, Gérald Chanques, Laurent Müller, Jean-Étienne Bazin, Antoine Monsel, Lucile Borao, Jean‐Marc Garcier, Jean‐Jacques Rouby, Bruno Pereira, Emmanuel Futier, Sophie Cayot, Godet Thomas, G. Renaud, Verlac Camille, Chabanne Russel, Cosserant Bernard, Blondonnet Raiko, Lautrette Alexandre, Eisenmann Nathanael, Muller Laurent, M.J. Pablo, Boutin Caroline, Barbar Saber, Roger Claire, Belafia Fouad, C Moussa, Monnin Marion, Conseil Matthieu, C. Julié, de Jong Audrey, Dargent Auguste, Andreu Pascal, Lebouvrier Thomas, Yoann Launey, Antoine Roquilly, Raphaël Cinotti, Boutin Caroline, Tellier Anne-Charlotte, Barbaz Mathilde, Cohen Benjamin, Lemarche Edouard, Bertrand Pierre-Marie, A. Charlotte, Zieleskiewicz Laurent, Hammad Emmanuelle, Duclos Garry, Mathie Calypso, Dupont Hervé, V. Benoit, Orban Jean-Christophe, Hervé Quintard, Thomas Rimmelé, Crozon-Clauzel Julien, Le Core Marinne, Fabien Grelon, Assefi Mona, Petitas Frank, M Jérôme, Molliex Serge, Hadanou Nanadougmar,

Sepsis Diagnosis and Treatment

The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care.We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov, NCT02149589.From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p<0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5-5·1; p=0·012.Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial.French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013).