The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.
Most patients suffering from acute lung injury or acute respiratory distress syndrome require mechanical ventilation. In this setting, positive end-expiratory pressure is used to improve arterial oxygenation. While the beneficial effect on clinical outcome of using low tidal volume is clearly proven, the best way to titrate PEEP is not known. Higher PEEP levels may better improve oxygenation and reduce ventilator-induced lung injury by reducing end-expiratory alveolar collapse but may also cause circulatory depression and aggravate lung injury from end-inspiratory overdistension. This trial compares the impact on outcome of two strategies for setting PEEP. In the "minimal alveolar distension" arm, PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H20). In the "maximal alveolar recruitment" arm, PEEP is set for a plateau pressure between 28 and 30 cm H20. A tidal volume of 6 ml/kg predicted body weight is used in the two arms. The goals for arterial oxygenation and PaCO2 are the same in the two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
768
Mortality at 28 days
Time frame: day 28
Mortality at 60 days
Time frame: day 60
In hospital mortality
Time frame: day 60
Ventilator free Days through day 28
Time frame: day 28
Number of new organ failure before day 28
Time frame: day 28
Proportion of patients alive and unassisted breathing at 28 days
Time frame: day 28
Number of patients with pneumothorax
Time frame: day 28
Number of days alive between the first positive "potential weanability test" and day 28
Time frame: day 28
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General Hospital of Aix en Provence
Aix-en-Provence, France
South Hospital of Amiens
Amiens, France
University Hospital of Amiens
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Angers, France
University Hospital of Angers
Angers, France
Victor Dupouy Hospital
Argenteuil, France
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Arras, France
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Avignon, France
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