Effet de la mise précoce en décubitus ventral sur la mortalité des malades avec syndrome de détresse respiratoire aiguë persistant et sévère. Étude Proseva. Présentation du protocole de recherche

There is a lot of experimental data showing that prone position (PP) can prevent or limit the ventilator-induced lung injury. However, three randomized controlled trials failed to demonstrate any clinical benefit. One trial has shown that the mortality was reduced by 25% from PP but this result did not reach the statistical significance due to lack of power. Therefore, the effect of PP on mortality in ARDS patients is an open issue. We have set up a multicenter prospective randomized controlled trial which aims at investigating the effect of PP on mortality in selected patients, namely patients with a persistent and severe ARDS as defined as PaO2/FIO2 less than 150 mmHg with PEEP of at least 5 cm H2O and FIO2 of at least 60% under protective mechanical ventilation (VT of 6 ml/kg ideal body weight). Patients are randomized into two groups: one in which the patients are left in a semi-recumbent supine position and the other in which the patients are turned to prone position for at least 16 h per day. The primary end-point is the Day 28 moratlity and secondary end-points Day 90 mortality and ventilator-associated pneumonia. A number of 230 patients per group has been computed to meet the requirements of a reduction of mortality from 60 to 45% by the PP at a first order risk of 5% and at a power of 90%. The study is ongoing since January 1st, 2008.