Optimal Prone Position Duration in Patients With ARDS Due to COVID-19: The Omelette Pilot Trial.

ABSTRACT

BACKGROUND: Prone position (PP) has been widely used in the COVID-19 pandemic for ARDS management. However, the optimal length of a PP session is still controversial. This study aimed to evaluate the effects of prolonged versus standard PP duration in subjects with ARDS due to COVID-19. METHODS: This was a single-center, randomized controlled, parallel, and open pilot trial including adult subjects diagnosed with severe ARDS due to COVID-19 receiving invasive mechanical ventilation that met criteria for PP between March-September 2021. Subjects were randomized to the intervention group of prolonged PP (48 h) versus the standard of care PP (∼16 h). The primary outcome variable for the trial was ventilator-free days (VFDs) to day 28. RESULTS: We enrolled 60 subjects. VFDs were not significantly different in the standard PP group (18 [interquartile range [IQR] 0-23] VFDs vs 7.5 [IQR 0-19.0] VFDs; difference, -10.5 (95% CI -3.5 to 19.0, P = .08). Prolonged PP was associated with longer time to successful extubation in survivors (13.00 [IQR 8.75-26.00] d vs 8.00 [IQR 5.00-10.25] d; difference, 5 [95% CI 0-15], P = .001). Prolonged PP was also significantly associated with longer ICU stay (18.5 [IQR 11.8-25.3] d vs 11.50 [IQR 7.75-25.00] d, P = .050) and extended administration of neuromuscular blockers (12.50 [IQR 5.75-20.00] d vs 5.0 [IQR 2.0-14.5] d, P = .005). Prolonged PP was associated with significant muscular impairment according to lower Medical Research Council values (59.6 [IQR 59.1-60.0] vs 56.5 [IQR 54.1-58.9], P = .02). CONCLUSIONS: Among subjects with severe ARDS due to COVID-19, there was no difference in 28-d VFDs between prolonged and standard PP strategy. However, prolonged PP was associated with a longer ICU stay, increased use of neuromuscular blockers, and greater muscular impairment. This suggests that prolonged PP is not superior to the current recommended standard of care.