Low‐Use vs. High‐Use Physical Restraint in Older Adults With Sepsis Receiving Mechanical Ventilation: A Multicenter Randomized Clinical Trial

BACKGROUND: Physical restraints are commonly used in patients receiving mechanical ventilation in the intensive care unit (ICU), yet evidence regarding their effectiveness in older patients with sepsis is limited. This study evaluated whether a low-use physical restraint strategy improves outcomes in older patients with sepsis requiring invasive mechanical ventilation. METHODS: This multicenter, open-label, randomized controlled trial was conducted in five ICUs in China from August 2023 to March 2026. Patients aged ≥ 65 years with invasive mechanical ventilation were randomly assigned (1:1) to a low-use restraint strategy (restraints applied only for severe agitation) or a high-use restraint strategy (routine restraint use until recovery of consciousness and liberation from mechanical ventilation). The primary outcome was days alive without delirium or coma within 7 days after randomization. Secondary outcomes included delirium incidence, ventilator-free days, coma-free days, sedative exposure, 28-day mortality, and safety events. Analyses were performed using intention-to-treat, per-protocol, and inverse probability weighting approaches. RESULTS: Among 485 randomized patients (median age, 74 years; 60.4% male), 244 received low-use and 241 high-use restraint. Delirium- and coma-free days did not differ between groups (adjusted mean difference, 0.17 days; 95% CI, -0.20 to 0.54; p = 0.37). Low-use restraint was associated with more ventilator-free days (0.69 days; 95% CI, 0.48-0.91; p < 0.001) and coma-free days (0.46 days; 95% CI, 0.19-0.74; p = 0.001). No significant between-group differences were observed in delirium incidence, sedative exposure, 28-day mortality, or safety outcomes. CONCLUSIONS: Among older mechanically ventilated patients with sepsis, a low-use physical restraint strategy did not improve days alive without delirium or coma but was associated with more ventilator-free and coma-free days. These findings suggest that reducing restraint use may facilitate short-term recovery, although the safety of restraint minimization requires further evaluation. TRAIL REGISTRATION: ClinicalTrials.gov identifier: ChiCTR1900025850.