Original Investigation 

Caring for the Critically Ill Patient

Restrictive vs Liberal Physical Restraint Strategies in Critically Ill Patients: The R2D2-ICU Randomized Clinical Trial

Romain Sonneville, Camille Couffignal, Florian Sigaud, et al

JAMA Published Online: March 17, 2026

doi: 10.1001/jama.2026.2897

Key Points

Question  Does a restrictive (low-use) wrist-strap physical restraint strategy, compared with a liberal (high-use) strategy, reduce coma or delirium in adult patients receiving mechanical ventilation in the intensive care unit?

Findings  In this randomized clinical trial of 405 adults receiving invasive mechanical ventilation, the number of days alive without coma or delirium during the first 14 days after randomization did not differ between the low- and high-use restraint strategies (6.67 vs 6.30 days). Delirium; self-extubation; day-90 mortality; and 90-day functional, cognitive, and psychological outcomes were similar between groups.

Meaning  In adult patients receiving mechanical ventilation in the intensive care unit, a low-use wrist-strap physical restraint strategy did not improve coma- or delirium-free days.

Abstract

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