NCT04273360: R2D2-ICU

Restrictive Use of Restraints and Delirium Duration in ICU

Completed NA Last updated 23 March 2026

What this trial tests

NA trial testing Systematic use group in Restraint, Physical in 423 participants. Completed in 8 September 2025.

Timeline

25 January 2021

Primary endpoint
2 July 2025

8 September 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	423
Start date	25 January 2021
Primary completion	2 July 2025
Estimated completion	8 September 2025
Sites	1 location across France

Drugs / interventions tested

• Systematic use group
• Restrictive use group

Conditions studied

• Restraint, Physical — all drugs for Restraint, Physical →
• Mechanical Ventilation — all drugs for Mechanical Ventilation →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Restraint, Physical or Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The R2D2-ICU study will be a prospective, parallel-group, open label, multicenter (6 centers) randomized controlled trial. All consecutive eligible patients will be included. Patients will be randomly assigned (1/1 ratio) to either systematic PR use (systematic use group) or restrictive PR use (restrictive use group). Patients in the restrictive PR group will be subjected to PR only in case of severe agitation defined by a RASS ≥ +3. Physical restraint will consist of wrist straps. In both groups, patients will receive standardized management for analgesia, sedation, delirium detection, weaning and early mobilization according to current guidelines. Concealment will be obtained using a computer-generated randomization scheme of various-sized blocks stratified by center, age (\< or ≥ 65 years) and coma at the beginning of invasive mechanical ventilation (D0)) through a centralized 24h/24h internet service. Investigation blinded to group assignment is not feasible. In both arms, patients' arousal will be evaluated twice a day until day 14 with the use of RASS. Patients with a RASS of -5 or -4 will be considered comatose (and will not be assessed for delirium). Patients with a RASS score ≥ -3 will be assessed for delirium with the use of the CAM-ICU scale twice a day.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Restrictive vs Liberal Physical Restraint Strategies in Critically Ill Patients: The R2D2-ICU Randomized Clinical Trial.
   Sonneville R, Couffignal C, Sigaud F, Thy M, et al · · 2026 · PMID 41841304 · DOI 10.1001/jama.2026.2897
2. Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial.
   Sonneville R, Couffignal C, Sigaud F, Godard V, et al · · 2024 · PMID 38631841 · DOI 10.1136/bmjopen-2023-083414