The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients. The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
702
Pressure ventilation mode allowing early spontaneous breathing
Medical Intensive Care Unit, University Hospital of Angers
Angers, France
all cause hospital mortality
participants will be followed for the duration of hospital stay, until day 60 maximum.
Time frame: hospital discharge
all causes mortality
Time frame: Day 28
number of days alive without mechanical ventilation
Time frame: day 28
number of days alive without organ failure
Time frame: day 28
number of patients with refractory hypoxemia
Time frame: day 7
number of patients requiring adjuvant treatment of hypoxemia
Time frame: day 7
number of days alive without sedation
Time frame: Day 28
total amount of sedative drugs
Time frame: between baseline and day 7
amount of sedative drugs received daily living
Time frame: between baseline and day 7
number of days alive without vasoactive drugs
Time frame: day 28
total amount of vasoactive drugs
Time frame: between baseline and day 7
amount of vasoactive drugs received daily living
Time frame: between baseline and day 7
Number of patients with a pneumothorax
Time frame: day 28
Duration of mechanical ventilation
Time frame: day 60
Duration of stay in ICU
Time frame: day 60
Changes in serum levels of proinflammatory cytokines
Time frame: Hour 1 and Hour 48
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