Limiting ICU Wrist Restraints Fails to Increase Delirium-Free Days

The Restraint Dilemma in the Intensive Care Unit

Delirium is a pervasive complication in the intensive care unit (ICU), affecting up to 80% of critically ill patients and significantly increasing the risk of prolonged mechanical ventilation, long-term cognitive dysfunction, and mortality [1, 2]. To prevent agitated patients from pulling out life-saving devices, clinicians frequently rely on physical restraints, such as wrist straps [3]. However, this practice presents a clinical paradox. While intended to ensure patient safety, physical restraints are strongly associated with psychological trauma, post-traumatic stress disorder, and an increased risk of developing delirium itself [3, 4]. Consequently, modern critical care guidelines emphasize minimizing restraint use as part of comprehensive delirium prevention bundles [2, 4]. A new randomized clinical trial now offers fresh insights into whether strictly limiting wrist-strap restraints actually translates to more delirium-free days for mechanically ventilated adults.

Comparing Restrictive and Liberal Restraint Protocols

To determine whether minimizing physical restraints improves neurological outcomes, investigators conducted an open-label randomized clinical trial across 10 intensive care units in France. Between January 2021 and January 2024, the trial enrolled 405 adult patients who had initiated invasive mechanical ventilation within the previous six hours and were expected to require respiratory support for at least 48 hours. The researchers randomized participants into two distinct intervention arms. The first group (n = 201) underwent a restrictive, low-use physical restraint strategy, where clinicians avoided wrist straps unless they became necessary due to severe agitation. The study defined severe agitation as a score of 3 or greater on the Richmond Agitation-Sedation Scale (a validated clinical tool measuring patient arousal from -5 for unresponsive to 4 for combative). The second group (n = 204) received a liberal, high-use strategy, which involved applying wrist straps systematically and reassessing them daily. In both groups, the protocol allowed clinicians to discontinue restraints in patients who were awake or extubated without delirium. To ensure standardized neurological assessments, the team measured delirium using the Confusion Assessment Method for the ICU (a standard bedside screening tool for detecting altered mental status in critically ill patients). The trial was registered under identifier NCT04273360.

Delirium and Coma Outcomes

Primary outcome data was available for 396 patients, representing a typical critically ill population. The median age was 65 years (interquartile range, 56 to 73 years), and 245 patients (62%) were male. To quantify baseline illness severity, the researchers calculated the Sequential Organ Failure Assessment score (a standard clinical tool that tracks dysfunction across six major organ systems to predict ICU mortality), which demonstrated a median of 7 (interquartile range, 4 to 10). The primary outcome was the number of days alive without coma or delirium during the first 14 days after randomization. When evaluating this neurological endpoint, the mean days alive without coma or delirium were 6.67 days (95% CI, 5.69 to 7.65) in the low-use strategy group and 6.30 days (95% CI, 5.35 to 7.24) in the high-use strategy group. The adjusted mean difference in days alive without coma or delirium between the low-use and high-use groups was 0.37 days (95% CI, -0.71 to 1.46; P = .51). Because this difference was not statistically significant, the findings indicate that a low-use wrist-strap strategy does not reduce days free of delirium or coma at 14 days compared with a high-use strategy among adult patients receiving mechanical ventilation.

Safety Profile and Self-Extubation Risk

Clinicians frequently rely on physical restraints due to the persistent fear that agitated patients might inadvertently remove life-sustaining airway devices. To address this critical safety concern, the researchers evaluated specific secondary outcomes, including the incidence of self-extubation and day-90 mortality. By tracking these metrics, the study aimed to determine whether withholding wrist straps compromised patient safety or led to adverse clinical events. The data demonstrated that minimizing physical restraints did not lead to a meaningful increase in accidental tube removal. Specifically, self-extubation occurred in 18 patients (9.2%) in the low-use strategy group and 17 patients (8.5%) in the high-use strategy group. Furthermore, the restrictive approach did not negatively impact long-term survival, as day-90 mortality was 37.2% in the low-use strategy group and 41.0% in the high-use strategy group. For practicing intensivists, these findings provide important clinical context. While a low-use restraint protocol does not increase delirium-free days, it appears entirely safe to implement without elevating the risk of accidental extubation or death, supporting a shift toward less restrictive care environments when clinically feasible.

References

1. Salluh JI, Wang H, Schneider EB, et al. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015. doi:10.1136/bmj.h2538

2. Park SY, Lee HB. Prevention and management of delirium in critically Ill adult patients in the intensive care unit: a review based on the 2018 PADIS guidelines. Acute and Critical Care. 2019. doi:10.4266/acc.2019.00451

3. Franks ZM, Alcock JA, Lam T, Haines KJ, Arora N, Ramanan M. Physical Restraints and Post-Traumatic Stress Disorder in Survivors of Critical Illness. A Systematic Review and Meta-analysis.. Annals of the American Thoracic Society. 2021. doi:10.1513/AnnalsATS.202006-738OC

4. Bazina AIA, Ahmed NTM, Elsaman SEA, Tammam HM. Effect of Implementing Delirium Prevention Bundle on Clinical Outcomes of Critically Ill Patients. Alexandria Scientific Nursing Journal. 2024. doi:10.21608/asalexu.2024.376238