ART
Trial question
What is the effect of lung recruitment maneuver and titrated PEEP in patients with moderate-to-severe ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 1010
1010 patients (379 female, 631 male).
Inclusion criteria: patients receiving invasive mechanical ventilation with moderate-to-severe ARDS of < 72 hours of duration.
Key exclusion criteria: use of increasing doses of vasoconstrictor drugs or mean arterial pressure < 65 mmHg; contraindications to hypercapnia; pneumothorax, subcutaneous emphysema, pneumomediastinum, or pneumatocele.
Interventions
N=501 lung recruitment and titrated PEEP (a strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory system compliance).
N=509 low PEEP (a strategy of low PEEP).
Primary outcome
Death at day 28
55.3%
49.3%
55.3 %
41.5 %
27.6 %
13.8 %
0.0 %
Lung recruitment and titrated
PEEP
Low
PEEP
Significant
increase ▲
NNH = 16
Significant increase in death at day 28 (55.3% vs. 49.3%; HR 1.2, 95% CI 1.01 to 1.42).
Secondary outcomes
Significant increase in death at 6 months (65.3% vs. 59.9%; HR 1.18, 95% CI 1.01 to 1.38).
Significant decrease in the number of ventilator-free days (5.3 days vs. 6.4 days; AD -1.1 days, 95% CI -2.1 to -0.1).
Significant increase in risk of pneumothorax requiring drainage (3.2% vs. 1.2%; AD 2%, 95% CI 0 to 4).
Safety outcomes
No significant differences in death in the ICU and hospital, refractory hypoxemia, severe acidosis, and cardiorespiratory arrest.
Significant difference in barotrauma (5.6% vs. 1.6%) and vasopressor use or hypotension (34.8% vs. 28.3%).
Conclusion
In patients receiving invasive mechanical ventilation with moderate-to-severe ARDS of < 72 hours of duration, lung recruitment and titrated PEEP were inferior to low PEEP with respect to death at day 28.
Reference
Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators, Alexandre Biasi Cavalcanti, Érica Aranha Suzumura et al. Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1335-1345.
Open reference URL