Elements of the "open lung concept" are being increasingly included in clinical ventilatory strategies. Despite encouraging experimental investigations to date, relatively few studies exist that examine the clinical application of the complete concept. The aim of this study was to prove that with effective recruitment maneuvers and titrated PEEP levels this concept is applicable in clinical settings. We sought to determine if it was possible to achieve a significant improvement in oxygenation and also to examine what side-effects resulted. Twenty consecutive patients who had had an acute lung injury (ALI) for less than 72 hours, with an oxygenation index (P/F-Ratio = quotient from arterial partial pressure of oxygen [PaO2] and the inspiratory fraction of oxygen [FiO2]) of less than 200 torr, and with a PEEP > or = 10 cmH2O were treated using a recruitment manoeuvre (RM). A PEEP was titrated to keep the lung open, and the patients were kept under pressure-controlled ventilation. The P/F-Ratio increased while using a recruitment pressure of 66 +/- 13 cmH2O from 137 +/- 41 to 381 +/- 150 torr (p < 0.001). The titrated PEEP which kept the lung open after recruitment was 17 +/- 3 cmH2O. One patient developed a pneumothorax. The dose of norepinephrine was increased in ten patients from 0.24 +/- 0.12 to 0.31 +/- 0.1 microgram/kg/min. Due to elevated liver enzymes within the first 48 hours, titrated PEEP had to be decreased in three patients. The clinical application of the "open lung concept" demonstrated a quick and effective improvement in oxygenation in many patients. Side-effects in some patients limited the use of high PEEP levels.