Résumé
Le syndrome de détresse respiratoire aiguë (SDRA) est une maladie pulmonaire et générale sévère dont la mortalité reste encore élevée. Les formes les plus graves de la maladie ont un pronostic encore plus sombre, avec des taux de mortalité dépassant 60 %, malgré le recours à des thérapeutiques adjonctives d’exception. Dans ces situations, certaines équipes proposent la mise en place d’un circuit extracorporel associant une pompe centrifuge et un oxygénateur à membrane, réalisant une assistance pulmonaire totale (oxygénation et épuration du CO2 du sang) ou ECMO pour extracorporeal membrane oxygenation. Le but de l’ECMO est alors de minimiser le traumatisme induit par la ventilation mécanique (VM) et de mettre le poumon au repos. Dans les dernières années, des progrès décisifs ont été réalisés dans la conception et la fabrication des circuits d’ECMO, les rendant plus « biocompatibles », performants et endurants. Le but de cet essai randomisé, multicentrique, ouvert, contrôlé est d’évaluer l’intérêt d’une assistance respiratoire précoce par ECMO veinoveineuse précoce dans les formes les plus sévères de SDRA. Les patients sélectionnés présenteront un SDRA défini selon les critères habituels et un rapport PaO2/FiO2 < 50 mmHg, avec FiO2 ≥ 80 % pendant plus de trois heures malgré une optimisation de la VM et le recours éventuel aux thérapeutiques adjonctives habituelles ou un rapport PaO2/FiO2 < 80 mmHg, avec FiO2 ≥ 80 % pendant plus de six heures malgré une optimisation de la VM et le recours éventuel aux thérapeutiques adjonctives habituelles ou un pH inférieur à 7,25 pendant plus de six heures (malgré l’augmentation de la fréquence respiratoire jusqu’à 35/min) résultant de la réduction du volume courant (Vt) et de la PEP pour maintenir la pression de plateau ≤ 32 cmH2O. Dans le groupe témoin, une prise en charge conventionnelle du SDRA sera mise en oeuvre, selon les modalités appliquées au groupe « recrutement pulmonaire maximal » de l’essai EXPRESS. L’objectif primaire est de montrer une réduction significative de la mortalité à j60. Pour une puissance de 80 % et un risque de première espèce de 5 % et en faisant l’hypothèse d’une mortalité de 60 % dans le groupe témoin et d’une réduction absolue de la mortalité de 20 % grâce à l’ECMO, la probabilité d’arrêter l’étude après avoir inclus 220 sujets est de 90 %, en se basant sur un test triangulaire. Ce projet s’intègre dans le cadre du réseau REVA (réseau européen de recherche en ventilation artificielle).
Abstract
The acute respiratory distress syndrome (ARDS) remains associated with an elevated rate of mortality that may exceed 60% in the most severe cases with a refractory hypoxemia. In these situations, the use of an extracorporeal membrane oxygenation (ECMO), combining a centrifugeal pump and an oxygen membrane, was proposed. The aim of ECMO is to minimize the trauma induced by mechanical ventilation (MV) and to allow the lungs to rest. The objective of this multicenter, international, randomized, open trial is to evaluate the impact on the morbidity and mortality of ECMO, early instituted after the diagnosis of an ARDS with an unfavorable outcome after 3–6 hours despite optimal ventilatory management and maximum medical treatment. Included patients will fulfill the following criteria: ARDS defined according to the usual criteria and PaO2/FiO2 ratio < 50 mmHg with FiO2 ≥ 80% for > 3 hours, despite the optimization of mechanical ventilation and use of adjunctive therapies or PaO2/FiO2 < 80 mmHg with FiO2 ≥ 80% for > 6 hours, despite the optimization of mechanical ventilation and use of adjunctive therapies or pH < 7.25 for > 6 hours (despite an increase of the respiratory rate up to 35/min) resulting from MV settings adjusted to keep a plateau pressure ≤ 32 cmH2O. In the control arm, standard ARDS management according to the modalities used for the “maximal pulmonary recruitment” group in the EXPRESS trial, will be performed. The primary endpoint is to achieve with ECMO a significantly lower mortality on day 60 following the randomization. With a 80%-power and a 5%-alpha-risk for the hypothesis of ECMO achieving a 20%-absolute mortality reduction and an estimated probability of 60%-mortality in the control arm, the characteristics of the study, calculated with a triangle test, indicate a 90%-probability of stopping the study before the inclusion of 220 subjects. This project will be conducted within the REVA (European network for research in mechanical ventilation).
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Combes, A. Extracorporeal membrane oxygenation (ECMO) pour les syndromes de détresse respiratoire aiguë (SDRA) sévères. L’essai EOLIA (ECMO to rescue Lung Injury in severe ARDS): un essai multicentrique international, randomisé, contrôlé en ouvert. Réanimation 20, 49–61 (2011). https://doi.org/10.1007/s13546-010-0002-8
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DOI: https://doi.org/10.1007/s13546-010-0002-8
Keywords
- Extracorporeal Membrane Oxygenation
- Adult Respiratory Distress Syndrome
- therapy
- Mortality assessment
- Randomized trial