Low-use wrist-strap restraint strategy did not improve days free of delirium or coma compared with high-use strategy in mechanically ventilated adults.

This study was a randomized clinical trial conducted across 10 intensive care units (ICUs) in France. The investigation focused on adult patients who had initiated invasive mechanical ventilation within the previous 6 hours and were expected to require ventilation for at least 48 hours. A total of 405 patients were enrolled, and data for 396 patients were available for the primary outcome analysis. The trial compared two distinct strategies for the use of wrist-strap physical restraints. The intervention group received a restrictive, low-use strategy where wrist straps were avoided unless necessary due to severe agitation, defined as a Richmond Agitation-Sedation Scale score of 3 or higher. The comparator group received a liberal, high-use strategy where wrist straps were applied systematically and reassessed daily.

The primary outcome measured was the number of days alive without coma or delirium during the first 14 days after randomization. In the low-use strategy group, the mean number of days alive without coma or delirium was 6.67 days (95% CI, 5.69-7.65). In the high-use strategy group, this metric was 6.30 days (95% CI, 5.35-7.24). The adjusted mean difference between the groups was 0.37 days. The 95% confidence interval for this difference ranged from -0.71 to 1.46 days, with a P value of .51. This result indicates no statistically significant difference between the two strategies regarding the primary endpoint.

Key secondary outcomes included the incidence of self-extubation and day-90 mortality. For self-extubation, 18 patients (9.2%) in the low-use strategy group experienced the event compared with 17 patients (8.5%) in the high-use strategy group. No p-value or effect size was reported for this comparison. Regarding day-90 mortality, 37.2% of patients in the low-use strategy group died compared with 41.0% in the high-use strategy group. Specific statistical measures for these secondary outcomes were not reported in the provided data.

Safety and tolerability findings were not reported in the available data. There were no reported adverse events, serious adverse events, discontinuations, or specific tolerability metrics associated with either the low-use or high-use restraint strategies. The study did not provide detailed data on the nature or frequency of adverse events beyond the primary and secondary outcome measures.

The study design and setting provide a specific context for ICU practice in France. However, the absence of reported limitations in the input data prevents a detailed discussion of potential biases or methodological constraints specific to this trial. The results should be interpreted within the context of the specific population of patients expected to require prolonged ventilation. The lack of significant difference in the primary outcome suggests that the liberal use of wrist straps did not result in worse outcomes regarding delirium or coma duration in this specific cohort.

These results imply that a low-use restraint strategy may not be inferior to a high-use strategy for preventing delirium or coma in the short term among mechanically ventilated adults. Clinicians should consider that reducing routine wrist-strap use does not appear to compromise the duration of consciousness or alertness in this setting. However, the study did not report on other potential benefits or harms of restraint use, such as skin integrity, falls, or patient comfort, which are important considerations in daily ICU care.

Several questions remain unanswered based on this evidence. The lack of reported safety data limits the ability to fully assess the risk-benefit profile of the low-use strategy. Additionally, the absence of statistical reporting for secondary outcomes like self-extubation and mortality prevents a robust comparison of these events between the two strategies. The study population was specific to patients initiating ventilation within 6 hours, which may limit the generalizability of findings to patients with different durations of pre-existing ventilation or other comorbidities. Further research may be needed to explore optimal restraint strategies that balance patient safety with the prevention of delirium.