Prone-Supine II
Trial question
Is prone positioning superior to supine positioning in patients with moderate and severe ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 342
342 patients (98 female, 244 male).
Inclusion criteria: adult patients with moderate and severe ARDS.
Key exclusion criteria: age < 16 years; > 72 hours since the diagnosis of ARDS; solid organ or bone marrow transplantation; contraindication to prone positioning including intracranial hypertension and spine or pelvic fractures.
Interventions
N=168 prone positioning (face down position ≥ 20 hours/day).
N=174 supine positioning (face up position).
Primary outcome
Death at day 28
31%
32.8%
32.8 %
24.6 %
16.4 %
8.2 %
0.0 %
Prone
positioning
Supine
positioning
No significant
difference ↔
No significant difference in death at day 28 (31% vs. 32.8%; RR 0.97, 95% CI 0.84 to 1.13).
Secondary outcomes
No significant difference in death in the ICU (38.1% vs. 42%; RR 0.94, 95% CI 0.79 to 1.12).
No significant difference in death at 6 months (47% vs. 52.3%; RR 0.9, 95% CI 0.73 to 1.11).
No significant difference in SOFA score (6.7 points vs. 6.8 points; AD -0.1 points, 95% CI -1.21 to 1.01).
Safety outcomes
No significant difference in displacement of thoracotomy tube.
Significant differences in need for increased sedation or muscle relaxants (80.4% vs. 56.3%), airway obstruction (50.6% vs. 33.9%), transient desaturation (63.7% vs. 50.6%).
Conclusion
In adult patients with moderate and severe ARDS, prone positioning was not superior to supine positioning with respect to death at day 28.
Reference
Paolo Taccone, Antonio Pesenti, Roberto Latini et al. Prone positioning in patients with moderate and severe acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2009 Nov 11;302(18):1977-84.
Open reference URL