NCT04957238: ARBORéa

Physical Restraints in Intensive Care Unit Patients

Status unknown NA Last updated 15 February 2024

What this trial tests

NA trial testing ARBORea decision-making tool in Critically Ill in 4,000 participants. Status unknown.

Timeline

18 May 2022

Primary endpoint
27 November 2025

27 February 2026

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	4,000
Start date	18 May 2022
Primary completion	27 November 2025
Estimated completion	27 February 2026
Sites	20 locations across France

Drugs / interventions tested

• ARBORea decision-making tool

Conditions studied

• Critically Ill — all drugs for Critically Ill →
• Intensive Care Unit Delirium — all drugs for Intensive Care Unit Delirium →
• Delirium Confusional State — all drugs for Delirium Confusional State →
• Agitation,Psychomotor — all drugs for Agitation,Psychomotor →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Critically Ill or Intensive Care Unit Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a major restriction of patients' individual freedom. French highest authority for health has defined, for geriatrics and psychiatric units, ten criteria of good practice for physical restraints' use. Routine practice reports critically ill patients' safety as main reason of use. This decision, often left to the sole discretion of nurses, varies according to their own representation of this risk, and depends on several factors: seniority in ICU, nurse to patient ratio and personal workload.

In order to reduce practices subjectivity and heterogeneity, we have developed a decision-making tool for physical restraints implementation. This tool is based on objective scales used on a daily basis concerning neurological status (Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU)). Disorientation or delirium can lead to severe incidents by promoting accidental removing of important devices such as arterial of venous line, drains among others. However, physical restraints are recognized as a major cause of delirium and agitation.

Critically ill patients require rigorous evaluation of organ dysfunctions necessitating adequate invasive equipments, with associated risks of unexpected removal or alteration. Such events could urge caregivers to use physical restraints. Based on recent literature, about a third of ICU patients are restrained, and accidental deconditioning is mainly observed within these particular patients.

In addition, three categories of patients have been defined according to the invasive nature of their equipment and therefore according to the risk associated with an unexpected withdrawal. Finally, presence of patient's family and their adherence to its surveillance were also implemented into the tool. Main study objective is to jointly investigate effectiveness and tolerance of a decision-making tool guiding physical restraints use in ICU patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol.
   Vidal P, Lambert C, Pereira B, Martinez R, et al · · 2025 · cited 1× · PMID 40398949 · DOI 10.1136/bmjopen-2024-085674