The Acute Respiratory Distress Network Trial: Assessment of Low Tidal Volume and Elevated End-Expiratory Pressure to Obviate
Lung Injury (ALVEOLI)
Objectives:
The ARDS Network is a consortium of clinical centers
and a coordinating center to design and test novel therapies for the treatment
of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). The
ARDS Network 01/03 trials included an investigation of the efficacy and safety
of Ketoconazole and Respiratory Management in the treatment of ALI and ARDS
(KARMA). The Ketoconazole arm of the KARMA study was later stopped due to an
inability to show efficacy. Patients continued to be randomized to the
respiratory management arms of the study (ARMA), which compared two ventilator
strategies: a tidal volume of 6 mL/kg versus 12 mL/kg. The LARMA phase of the
study investigated the efficacy of Lisofylline and Respiratory Management. The
objective of the ALVEOLI study was to compare clinical outcomes of patients
with ALI and ARDS treated with a higher end-expiratory lung volume/lower FiO2
versus a lower end-expiratory lung volume/higher FiO2 ventilation strategy. The
ALVEOLI study tested the hypothesis that mortality from ALI and ARDS would be
reduced with a mechanical ventilation strategy designed to prevent lung injury
from repeated collapse of bronchioles and alveoli at end-expiration.
Background:
Most patients requiring mechanical ventilation for ALI
and ARDS receive positive end-expiratory pressure (PEEP) of 5 to 12 cm of
water. Higher PEEP levels may improve oxygenation and reduce ventilator-induced
lung injury but may also cause circulatory depression and lung injury from
overdistention. PEEP levels higher than traditional levels may reduce
ventilator-induced lung injury by decreasing the proportion of nonaerated lung
and higher PEEP levels may allow arterial-oxygenation goals to be met at a
lower level of inspired oxygen (FiO2).
Subjects:
Patients 14 years of age or more, intubated and
receiving mechanical ventilation with a sudden decrease in the ratio of the
partial pressure of arterial oxygen (PaO2) to FiO2 of 300 or less, recent
appearance of bilateral pulmonary infiltrates consistent with the presence of
edema, and no evidence of left atrial hypertension. A total of 549 patients
were randomized to receive mechanical ventilation with either lower or higher
PEEP levels, which were set according to different tables of predetermined
combinations of PEEP and fraction of inspired oxygen.
Conclusions:
Patients with acute lung injury and ARDS who receive
mechanical ventilation with a tidal-volume goal of 6 ml per kilogram of
predicted body weight and an end-inspiratory plateau-pressure limit of 30 cm of
water, clinical outcomes were statistically similar whether lower or higher
PEEP levels are used. (N Engl J Med 2004;351:327-336).
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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