Restrictive Use of Restraints and Delirium Duration in ICU

NCT04273360 | Completed

• 1 other identifier: APHP190776
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Restraint, Physical; Mechanical Ventilation

Keywords

Physical contention; ICU; mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• number of delirium-free days during the first 14 days (D14) after randomization (D0) measured by Confusion Assessment Method for the ICU (CAM-ICU)

  to assess whether a restrictive use of PR, in comparison to a systematic use, decreases delirium duration during the first 14 days (D14) after randomization (D0)

  14 days

• Number of coma free days during the first 14 days (D14) after randomization (D0) measured by RASS score

  14 days

Secondary Outcomes (21)

• Number of days on delirium until ICU discharge

  up to 90 days

• Proportion of positive CAM-ICU/total number of CAM-ICU performed until ICU discharge

  up to 90 days

• percentage of patients with at least one day of delirium (positive CAM-ICU) between Day0-Day14

  14 days

• Number of days alive with agitation (RASS score ≥ +2) between Day0-Day14

  14 days

• Total cumulative dose of analgesics infusion between Day0-Day14

  14 days

Study Arms (2)

Systematic use group

ACTIVE COMPARATOR

Other: Systematic use group

Restrictive use group

EXPERIMENTAL

Other: Restrictive use group

Interventions

Systematic use group OTHER

Patients in this group will be subjected to initial systematic PR, which will be re-evaluated every day every day between day 0 and day 14

Systematic use group

Restrictive use group OTHER

Patients in this group will be subjected to PR only in case of severe agitation, defined by a RASS ≥ +3 on any given day between day 0 and day 14

Restrictive use group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fulfilling all the following criteria will be eligible:
• Adults ≥ 18 years
• MV expected for at least ≥ 48 hours
• Invasive MV in the ICU for a duration inferior to 6 hours
• eligible to prescription for physical contention

You may not qualify if:

• Documented delirium prior to ICU admission according to the CAM-ICU
• History of dementia (Mini mental test \< 24)
• Alcoholic withdrawal syndrome expected
• Admission for any neurological disease including post-cardiopulmonary resuscitation (including cardiac arrest, stroke, traumatic brain injury, meningoencephalitis, and status epilepticus)
• Serious auditory or visual disorders
• Unable to understand French
• Pregnant or lactating women
• SAPS II \> 65 points at screening
• Do-not-resuscitate orders (advance directives)
• No affiliation to a social security regime (beneficiary or assignee)
• Patient already involved in another interventional clinical research whose main objective is related to delirium

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Related Publications (2)

• Sonneville R, Couffignal C, Sigaud F, Godard V, Audibert J, Contou D, Celier A, Djibre M, Schmidt J, Jaquet P, Mekontso Dessap A, Bourel C, Bellot R, Roy C, Lamara F, Essardy F, Timsit JF, Cornic R, Bouadma L; R2D2-ICU investigators. 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. BMJ Open. 2024 Apr 17;14(4):e083414. doi: 10.1136/bmjopen-2023-083414.

  PMID: 38631841 RESULT

• Sonneville R, Couffignal C, Sigaud F, Thy M, Godard V, Audibert J, Contou D, Celier A, Djibre M, Rambaud T, Jaquet P, Mekontso Dessap A, Bourel C, Belot R, Roy C, Nait Sidenas F, Essardy F, Timsit JF, Cornic R, Bouadma L; R2D2-ICU Investigator Study Group. Restrictive vs Liberal Physical Restraint Strategies in Critically Ill Patients: The R2D2-ICU Randomized Clinical Trial. JAMA. 2026 Mar 17. doi: 10.1001/jama.2026.2897. Online ahead of print.

  PMID: 41841304 RESULT

Study Officials

• Romain Sonneville, MD, PhD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 18, 2020
• Study Start: January 25, 2021
• Primary Completion: July 2, 2025
• Study Completion: September 8, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: For all inquiries, please contact the following : drc-secretariat-promotion@aphp.fr

Locations

FR (1)