Acute Lung Injury Clinical Trial
Official title:
Acute Lung Injury: Epidemiology and Natural History. The ALIEN Study
Acute lung injury is a clinical syndrome of rapid onset of acute respiratory failure. It represents a significant public health issue. Patients with acute lung injury require admission into critical care units for advanced life support and utilize considerable health care resources. Published epidemiological studies on acute lung injury in the last 20 years are difficult to compare because they used different definitions and length of time for evaluation. Less than five studies have collected information for an entire year, and none of them have evaluated the degree of oxygenation failure under standard settings. We will perform a one-year prospective audit of all patients admitted with acute lung injury in almost 40 ICUs in Spain.
Acute lung injury (ALI) is a clinical syndrome of rapid onset of non-cardiogenic pulmonary
edema manifested clinically by hypoxemia (PaO2/FiO2≤300 mmHg) and bilateral pulmonary
infiltrates. When the hypoxemia is severe (PaO2/FiO2≤200 mmHg) it is termed the acute
respiratory distress syndrome (ARDS). It represents a significant public health issue.
Patients with ALI or ARDS require admission into critical care units for advanced life
support and utilize considerable health care resources.
An immense plethora of translational knowledge has been acquired since the first description
of ARDS in 1967. However, estimates of the incidence of ARDS and ALI have varied widely, and
the true magnitude of this health problem still remains unclear. Current estimates of the
incidence of ALI/ARDS range from 15 to 80 cases per 100.000 population, or almost 40.000
cases per year in Spain. Combined mortality rates for ALI/ARDS range between 30-45%. ALI and
ARDS occur as a complication or as the primary cause of critical illness in patients, usually
after severe infection or trauma.
Published epidemiological studies on ALI and ARDS in the last 20 years are difficult to
compare. Some reports have used different definitions for ALI and ARDS and others have
evaluated the incidence during a short period of time (from days to several weeks) and then
extrapolated their data to estimates of a one-year incidence. Very few studies have collected
information for an entire year, and none of them have evaluated the degree of hypoxemia under
standard ventilatory settings, as it has been proposed recently by the HELP Network (Am J
Respir Crit Care Med 2007; 176:795-804).
As a result, we propose to perform a one-year prospective audit of all ALI and ARDS patients
managed in 40 ICUs from 17 Spanish provinces (15 provinces in the mainland and 2 provinces in
the Canary Islands). We intend to collect data from all patients admitted with or developing
ALI/ARDS with the aim to understand the epidemiology and natural history of acute lung
injury. These provinces are scattered through the Spain and are representative of the
demographic differences across the country.
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