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Trial question
What is the role of high-frequency oscillatory ventilation in patients with early ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.3% female
58.7% male
N = 1200
1200 patients (228 female, 320 male).
Inclusion criteria: adult patients with new-onset, moderate-to-severe ARDS.
Key exclusion criteria: hypoxemia primarily related to LA hypertension, suspected vasculitic pulmonary hemorrhage, neuromuscular disorders, severe chronic respiratory disease, or preexisting conditions with an expected 6-month mortality > 50%, at risk for intracranial hypertension.
Interventions
N=275 high-frequency oscillatory ventilation (targeting improved lung recruitment).
N=273 low tidal volume ventilation (low tidal volumes and high PEEP).
Primary outcome
In-hospital death
47%
35%
47.0 %
35.3 %
23.5 %
11.8 %
0.0 %
High-frequency oscillatory ventilation
Low tidal volume ventilation
Significant increase ▲
NNH = 8
Significant increase in in-hospital death (47% vs. 35%; RR 1.33, 95% CI 1.09 to 1.64).
Secondary outcomes
No significant difference in new barotrauma (18% vs. 13%; RR 1.37, 95% CI 0.91 to 2.06).
Significant decrease in refractory hypoxemia (7% vs. 14%; RR 0.5, 95% CI 0.29 to 0.84).
No significant difference in refractory acidosis (3% vs. 3%; RR 1.12, 95% CI 0.44 to 2.85).
Conclusion
In adult patients with new-onset, moderate-to-severe ARDS, high-frequency oscillatory ventilation was inferior to low tidal volume ventilation with respect to a in-hospital death.
Reference
Ferguson ND, Cook DJ, Guyatt GH et al. High-frequency oscillation in early acute respiratory distress syndrome. N Engl J Med. 2013 Feb 28;368(9):795-805.
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