Low-Use Restraint Strategy Did Not Improve Delirium- and Coma-Free Days in Older Patients With Sepsis

In a multicenter, open-label randomized trial of 485 mechanically ventilated adults aged 65 years or older with sepsis, a low-use restraint strategy did not improve the primary outcome of days alive without delirium or coma. It was associated with more ventilator-free and coma-free days, while mortality and reported safety outcomes did not differ significantly.

Primary delirium- and coma-free outcome did not differ.
Low-use strategy was associated with more ventilator-free days.
Mortality and reported safety outcomes did not significantly differ.
Further evaluation of restraint-minimization safety is needed.

Physical restraints are often used in mechanically ventilated ICU patients, but their benefits and risks in older adults with sepsis are uncertain. In this multicenter, open-label randomized trial conducted in five Chinese ICUs, 485 patients aged 65 years or older were assigned to low-use restraints—used only for severe agitation—or high-use restraints, used routinely until consciousness recovered and mechanical ventilation ended. The primary outcome was days alive without delirium or coma within seven days of randomization.

The primary outcome did not differ significantly between groups: the adjusted mean difference was 0.17 days (95% CI, −0.20 to 0.54; p=0.37). The low-use group had more ventilator-free days (difference, 0.69; 95% CI, 0.48–0.91) and coma-free days (difference, 0.46; 95% CI, 0.19–0.74). Delirium incidence, sedative exposure, 28-day mortality, and safety outcomes showed no significant between-group differences.

The results suggest possible short-term recovery benefits but do not establish improvement in the primary outcome or demonstrate that restraint minimization is safer. The open-label design, five-ICU setting, and limited follow-up are relevant considerations; further evaluation of safety is needed.

In practice

For older adults with sepsis receiving invasive mechanical ventilation, this trial found that a strategy reserving physical restraints for severe agitation did not improve days alive without delirium or coma over seven days. It was associated with modestly more ventilator-free and coma-free days, without significant differences in 28-day mortality or reported safety outcomes. These findings are not sufficient to establish restraint minimization as safer or to change practice on their own; the open-label design and limited setting and follow-up warrant caution.

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Source

Journal of the American Geriatrics Society: Low‐Use vs. High‐Use Physical Restraint in Older Adults With Sepsis Receiving Mechanical Ventilation: A Multicenter Randomized Clinical Trial ↗

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