Low-use restraint in ventilated older adults with sepsis: more ventilator-free days, similar safety events

Design

Multicentre, open-label randomised controlled trial

Population

485 ventilated adults aged ≥65 with sepsis in five Chinese ICUs

Primary outcome

Days alive without delirium or coma within 7 days

Effect

0.17 days (95% CI −0.20 to 0.54); ventilator-free days +0.69 (0.48–0.91)

An open-label randomised trial in five Chinese ICUs assigned 485 patients aged 65 or over (median age 74) with sepsis on invasive mechanical ventilation to low-use restraint — applied only for severe agitation — or high-use restraint, applied routinely until the patient was awake and off the ventilator. The primary outcome was days alive without delirium or coma in the first 7 days.

The primary outcome did not differ (adjusted difference 0.17 days, 95% CI −0.20 to 0.54). Low-use restraint was associated with more ventilator-free days (0.69, 0.48–0.91) and coma-free days (0.46, 0.19–0.74). Delirium incidence, sedative exposure, 28-day mortality and safety events did not differ.

The primary endpoint was negative and the gains are modest secondary findings in an unblinded trial. Still, routine restraint did not make patients safer, and reducing it did not increase harm in this trial. That supports restricting restraint to genuine need rather than using it by default, though the authors call for further safety data.

• Consider restricting physical restraint to severe agitation rather than applying it routinely in ventilated older patients.
• Expect no increase in safety events or mortality with a low-use approach, based on this trial.
• Pair restraint reduction with analgesia, sedation targets and delirium screening.
• Audit restraint use in your ICU against a documented indication.

Why it matters

Routine restraint is still common in many ICUs, and this trial found no safety gain from it.

Don't overread it

The primary endpoint was negative; ventilator-free and coma-free gains are secondary findings.

The statistics, in plain English

The primary result's interval (−0.20 to 0.54 days) includes zero, so no effect on delirium- or coma-free days was shown. The ventilator-free difference of about 0.7 days is significant but is a secondary outcome in an open-label trial.

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