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ARDSNet

Trial question
Is ventilation with lower tidal volumes superior to traditional tidal volume in patients with ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 861
861 patients (349 female, 512 male)
Inclusion criteria: patients with ARDS and acute lung injury
Key exclusion criteria: younger than 18 years of age; pregnancy; increased ICP, neuromuscular disease that could impair spontaneous breathing, sickle cell disease, or severe chronic respiratory disease; bone marrow or lung transplantation; chronic liver disease
Interventions
N=432 ventilation with lower tidal volumes (initial tidal volume of 6 mL/kg of predicted body weight and a plateau pressure ≤ 30 cmH₂O)
N=429 traditional tidal volume (initial tidal volume of 12 mL/kg of predicted body weight and plateau pressure ≤ 50 cmH₂O)
Primary outcome
Hospital death
31
39.8
39.8 %
29.8 %
19.9 %
9.9 %
0.0 %
Ventilation with lower tidal volumes
Traditional tidal volume
Significant decrease ▼
NNT = 11
Significant decrease in hospital death (31% vs. 39.8%; RR 0.78, 95% CI 2.4 to 15.3)
Secondary outcomes
Significant increase in ventilator-free days at 28 days (12 days vs. 10 days; ARD 2, 95% CI 0.55 to 3.45)
Conclusion
In patients with ARDS and acute lung injury, ventilation with lower tidal volumes were superior to traditional tidal volume with respect to hospital death.
Reference
Brower RG, Matthay MA, Morris A et al. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8.
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