EPVent2
Trial question
What is the effect of titrating PEEP with an esophageal pressure-guided strategy among patients with moderate-to-severe ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 200
200 patients (92 female, 108 male).
Inclusion criteria: mechanically ventilated patients aged 16 years and older with moderate-to-severe ARDS.
Key exclusion criteria: contraindication to esophageal instrumentation, high PEEP, severe coagulopathy, history of lung or liver transplantation, elevated ICP, neuromuscular disease, severe chronic liver disease.
Interventions
N=102 esophageal-pressure guided mechanical ventilation (PEEP titration guided by esophageal pressure adjusted as needed to maintain end-expiratory PL between 0 to 6 cmH₂O).
N=98 high PEEP mechanical ventilation (PEEP adjusted to maintain the lowest PEEP-FiO2 combination possible on the empirical table while maintaining oxygenation goals).
Primary outcome
Rate of death and days free from mechanical ventilation among survivors through day 28
49.6%
50.4%
50.4 %
37.8 %
25.2 %
12.6 %
0.0 %
Esophageal-pressure guided mechanical
ventilation
High PEEP mechanical
ventilation
No significant
difference ↔
No significant difference in the rate of death and days free from mechanical ventilation among survivors through day 28 (49.6% vs. 50.4%; ARD -0.8, 95% CI -15.14 to 13.54).
Secondary outcomes
No significant difference in the rate of death through day 28 (32.4% vs. 30.6%; AD 1.7%, 95% CI -11.1 to 14.6).
No significant difference in days free from mechanical ventilation among survivors through day 28 (22 days vs. 21 days).
Borderline significant increase in ventilator-free days through day 28 (15.5 days vs. 17.5 days).
Safety outcomes
No significant differences in shock-free days, pneumothorax, barotrauma.
Significant difference in rescue therapy (3.9% vs. 12.2%).
Conclusion
In mechanically ventilated patients aged 16 years and older with moderate-to-severe ARDS, esophageal-pressure guided mechanical ventilation was not superior to high PEEP mechanical ventilation with respect to the rate of death and days free from mechanical ventilation among survivors through day 28.
Reference
Jeremy R Beitler, Todd Sarge, Valerie M Banner-Goodspeed et al. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857.
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