IMPORTANCE: The effect of wrist-strap physical restraints on outcomes in patients receiving mechanical ventilation in the intensive care unit (ICU) remains uncertain.
OBJECTIVE: To investigate the effect of a low-use wrist-strap physical restraint strategy in critically ill patients receiving invasive mechanical ventilation.
DESIGN, SETTING, AND PARTICIPANTS: Open-label randomized clinical trial conducted across 10 ICUs in France. Between January 5, 2021, and January 2, 2024, 405 adult patients who had initiated invasive mechanical ventilation within the previous 6 hours and were expected to require ventilation for at least 48 hours were enrolled. Follow-up was completed on May 17, 2024. Statistical analysis was conducted from June 1, 2025, to December 15, 2025.
INTERVENTIONS: Patients were randomized to undergo either a restrictive, low-use physical restraint strategy (wrist straps avoided unless necessary because of severe agitation, defined as a Richmond Agitation-Sedation Scale score of =3 [on a scale from -5 (unresponsive) to 4 (combative)]; n = 201) or a liberal, high-use strategy (wrist straps applied systematically and reassessed daily; n = 204). Discontinuation of restraints was allowed in patients who were awake or extubated without delirium (measured via the Confusion Assessment Method for the ICU).
MAIN OUTCOMES AND MEASURES: The primary outcome was the number of days alive without coma or delirium during the first 14 days after randomization. Secondary outcomes included incidence of self-extubation and day-90 mortality.
RESULTS: Among 396 patients with available primary outcome data, the median (IQR) age was 65 (56-73) years, 245 (62%) were male, and the median (IQR) Sequential Organ Failure Assessment score was 7 (4-10). The mean days alive without coma or delirium were 6.67 days (95% CI, 5.69-7.65) in the low-use strategy group and 6.30 days (95% CI, 5.35-7.24) in the high-use strategy group (adjusted mean difference, 0.37 days [95% CI, -0.71 to 1.46]; P = .51). Self-extubation occurred in 18 patients (9.2%) in the low-use strategy group and 17 (8.5%) in the high-use strategy group, and day-90 mortality was 37.2% and 41.0%, respectively.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, among adult patients receiving mechanical ventilation in the ICU, a low-use wrist-strap physical restraint strategy compared with a high-use strategy did not reduce days free of delirium or coma at 14 days.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04273360.
| Discipline Area | Score |
|---|---|
| Respirology/Pulmonology |  |
| Intensivist/Critical Care | |
| Hospital Doctor/Hospitalists |  |
| Internal Medicine | |
important data and key to call out the exclusion criteria as this proposition is carefully selected for specific patients.
The research results of this R2D2-ICU RCT based on adult ICUs in France agrees with what I have observed in clinical practice. The benefit of their research findings proves the mean difference between the 2-point low-wrist strap restraints and high-wrist strap restraints is not clinically significant (0.37, 95% CI -0.71-1.46) among adult patients, who are at least 65 years old with medical co-morbidities like hypertension, respiratory failure, and require sedation to reduce delirium or coma in a fortnight of ICU admission.
Methodologically sound multicenter RCT (low risk of bias, adequate randomization, appropriate primary outcome) with sufficient sample size (n=396) to detect a 2-day difference in delirium-free/coma-free days, but the observed effect (0.37 days, 95% CI -0.71 to 1.46) was substantially smaller than the minimal clinically important difference, suggesting true equivalence between strategies rather than inadequate power. Limited newsworthiness for changing clinical practice - this trial provides reassuring evidence that restrictive physical restraint strategies are safe (no increase in self-extubation: 9.2% vs 8.5%), but offers no compelling reason to abandon current institutional practices, as both approaches yielded equivalent outcomes for delirium, coma, and mortality.
Novel study of restraints for patients intubated in the ICU did not find significantly different outcomes or psychological trauma in patients with restrictive physical restraint vs liberal physical restraints. Exclusion of patients with alcohol withdrawal and other neurological events may have greatly skewed the results.
This is a well conducted trial comparing high and low physical restraints for ICU patients. This is a common practice and there are sparse data to guide practice. This is the first major RCT on this topic. Somewhat surprisingly, using less restraints did not result in less delirium/coma as an outcome, nor did it change patients safety or need for safety interventions (unplanned extubations). The authors appropriately describe the null results, but some abstractions of this paper have suggested that the trial favors the lesser use of restraints, which is not shown particularly in a trial designed to show superiority/difference rather than non-inferiority.