BILEVEL-APRV
Trial question
What is the effect of early application of airway pressure release ventilation in patients with ARDS?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 138
138 patients (47 female, 91 male).
Inclusion criteria: patients with ARDS who received mechanical ventilation for < 48 hours.
Key exclusion criteria: anticipated duration of invasive mechanical ventilation < 48 hours; intracranial hypertension; severe COPD; barotrauma; refractory shock; pregnancy.
Interventions
N=71 airway pressure release ventilation (bi-level airway pressure ventilation-airway pressure release ventilation mode, combination with spontaneous breathing).
N=67 low tidal volume lung protective ventilation (volume-controlled ventilation or pressure-controlled ventilation mode combination with adequate PEEP level).
Primary outcome
Number of days without mechanical ventilation at 28 days
19 days
2 days
19.0 days
14.3 days
9.5 days
4.8 days
0.0 days
Airway pressure release
ventilation
Low tidal volume lung protective
ventilation
Significant
increase ▲
Significant increase in the number of days without mechanical ventilation at 28 days (19 days vs. 2 days; AD 17 days, 95% CI 6.91 to 27.09).
Secondary outcomes
No significant difference in death during ICU stay (19.7% vs. 34.3%; RR 0.57, 95% CI -0.01 to 1.15).
Significant decrease in length of ICU stay (15 days vs. 20 days; AD -5 days, 95% CI -9.03 to -0.97).
No significant difference in length of hospital stay (21 days vs. 27 days; AD -6 days, 95% CI -12.14 to 0.14).
Safety outcomes
No significant differences in pneumothorax between day 1 and day 28, receipt of inhaled nitric oxide, and high-frequency oscillatory ventilation.
Significant differences in successful extubation (66.2% vs. 38.8%), tracheostomy (12.7% vs. 29.9%), and receipt of neuromuscular blockers (2.8% vs. 13.4%).
Conclusion
In patients with ARDS who received mechanical ventilation for < 48 hours, airway pressure release ventilation was superior to low tidal volume lung protective ventilation with respect to number of days without mechanical ventilation at 28 days.
Reference
Yongfang Zhou, Xiaodong Jin, Yinxia Lv et al. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659.
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