The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation

Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14.


Purpose: While our understanding of the pathogenesis and management of acute respiratory distress syndrome (ARDS) has improved over the past decade, estimates of its incidence have been controversial. The goal of this study was to examine ARDS incidence and outcome under current lung protective ventilatory support practices before and after the diagnosis of ARDS.

Methods: This was a 1-year prospective, multicenter, observational study in 13 geographical areas of Spain (serving a population of 3.55 million at least 18 years of age) between November 2008 and October 2009. Subjects comprised all consecutive patients meeting American-European Consensus Criteria for ARDS. Data on ventilatory management, gas exchange, hemodynamics, and organ dysfunction were collected.

Results: A total of 255 mechanically ventilated patients fulfilled the ARDS definition, representing an incidence of 7.2/100,000 population/year. Pneumonia and sepsis were the most common causes of ARDS. At the time of meeting ARDS criteria, mean PaO(2)/FiO(2) was 114 ± 40 mmHg, mean tidal volume was 7.2 ± 1.1 ml/kg predicted body weight, mean plateau pressure was 26 ± 5 cmH(2)O, and mean positive end-expiratory pressure (PEEP) was 9.3 ± 2.4 cmH(2)O. Overall ARDS intensive care unit (ICU) and hospital mortality was 42.7% (95%CI 37.7-47.8) and 47.8% (95%CI 42.8-53.0), respectively.

Conclusions: This is the first study to prospectively estimate the ARDS incidence during the routine application of lung protective ventilation. Our findings support previous estimates in Europe and are an order of magnitude lower than those reported in the USA and Australia. Despite use of lung protective ventilation, overall ICU and hospital mortality of ARDS patients is still higher than 40%.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Female
  • Humans
  • Intensive Care Units
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care*
  • Prospective Studies
  • Respiration, Artificial / methods*
  • Respiratory Distress Syndrome / diagnosis
  • Respiratory Distress Syndrome / epidemiology*
  • Respiratory Distress Syndrome / etiology
  • Respiratory Distress Syndrome / therapy
  • Spain / epidemiology
  • Ventilator-Induced Lung Injury / prevention & control*