Early mobilization for mechanical ventilation for sepsis or acute respiratory failure (EVER): a multicenter randomized controlled trial with 12-month outcomes.

Abstract

Early mobilization is recommended for adults on mechanical ventilation, but the timing, the dose, and the real-world effectiveness, particularly in Asian ICUs, remain unclear. We assessed whether a structured six-step early mobilization programme enhances functional status at ICU discharge and longer-term recovery. A multicenter, randomized, open-label study was conducted across five tertiary hospitals in South Korea (September 2020 to July 2024). Adult patients with sepsis or respiratory failure anticipated to require invasive ventilation for ≥ 48 h were randomly assigned (1:1) to the intervention or usual care. The primary outcome was the FSS-ICU at ICU discharge. Secondary outcomes included in-hospital mortality, muscle strength, physical performance, and patient-reported outcomes evaluated at 1, 3, 6, and 12 months. Analyses followed the intention-to-treat principle. We enrolled 169 participants (93 intervention; 76 usual care). At ICU discharge, the FSS-ICU did not differ between groups (mean 23.6 [SD 11.8] vs. 22.2 [SD 10.8]; P = 0.44). The intervention group began mobilization earlier (median 30.0 vs. 45.9 h), underwent more sessions (median 11 vs. 4), and accumulated more mobilization time (median 330 vs. 120 min). Patients achieving mobilization Step ≥ 4 (sit to stand or higher) had higher FSS-ICU at ICU discharge compared with matched usual care (mean 30.6 vs. 23.3; P < 0.01). Long-term outcomes (EQ-5D, SF-36 PCS/MCS, IES-R-K, MoCA-BLIND, and PICS) improved similarly in both groups over 12 months without significant differences. In this multicenter randomized controlled trial of mechanically ventilated patients with sepsis or acute respiratory failure, a protocolized early mobilization program did not improve functional status at ICU discharge or at 12 months compared with usual care. NCT04582760, registered 12 October 2020.