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New tool aims to reduce physical restraints in ICUs

NCT ID NCT04957238

Disease control Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial tests a decision-making tool designed to help ICU staff decide when to use physical restraints. The tool uses objective measures of a patient's mental state and equipment needs, along with family involvement. The goal is to reduce the use of restraints and related incidents, while maintaining patient safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARBORea decision-making tool
What this could lead to
If effective, this tool could reduce the use of physical restraints in ICUs, improving patient safety and comfort.
What could go wrong
The tool may not change practice as expected, or could lead to unintended incidents if restraints are withheld inappropriately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4,000 people

The number who actually took part.

Started

May 2022

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient, male or female, over 18 years of age, hospitalized in ICU for at least 48 hours. * Consent to participate in the patient's study or authorization to carry out the research collected from the designated trustworthy person (failing this, a family member, or failing this, a close and stable relation with the person concerned) according to the modalities described in Title II of the book of the First Public Health Code. If no relative is present, the patient may be included on the advice of the investigator (article L. 1111-6). A consent form for continuation of the study and use of the data will then be signed by the patient if and when the patient is again conscious and lucid, or if the patient is unable to express consent, authorization to continue the research will be obtained from the designated trusted person. * Patient covered by a social security system. Exclusion Criteria: * Predictable and uninterrupted maintenance of deep sedation throughout the duration of the stay, due to the seriousness of the lesions, from the moment the patient is admitted to the intensive care unit. * Lack of predictable remission of a severe coma present on admission to intensive care. * Refusal to participate by the patient, or by the trusted person contacted by default. * Patient with DNR (do not resuscitate) orders. * Patient under legal protection. * Patient already included in the protocol during another stay in resuscitation

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Conditions

The condition(s) this trial relates to.

Confusion Critical Illness delirium Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation,psychomotor Critically ill Delirium confusional state Intensive care unit delirium

Contacts and locations

Locations

  • Assistance Publique-Hôpitaux de Marseille - La Timone

    Marseille, France

  • CH Henri Mondor

    Aurillac, France

  • CH de Saint Malo

    St-Malo, France

  • Centre Hospitalier Moulins-Yzeure

    Moulins, France

  • Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot

    Lyon, France

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, France

  • Centre Hospitalier Universitaire de Dijon

    Dijon, France

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, France

  • Centre Hospitalier Universitaire de Nice

    Nice, France

  • Centre Hospitalier Universitaire de Saint-Etienne

    Saint-Etienne, France

  • Centre Hospitalier Universitaire de Strasbourg - Réa Chirurgicale

    Strasbourg, France

  • Centre Hospitalier Universitaire de Strasbourg -MIR

    Strasbourg, France

  • Centre Hospitalier d'Avignon

    Avignon, France

  • Centre Hospitalier de Salon-de-Provence

    Salon-de-Provence, France

  • Centre Hospitalier de Vichy

    Vichy, France

  • Centre Hospitalier du Puy en Velay

    Le Puy-en-Velay, France

  • Centre de Lutte Contre le Cancer Jean-Perrin

    Clermont-Ferrand, France

  • Hôpital Nord Franche-Comté

    Belfort, France

  • Hôpital de la Pitié Salpétrière

    Paris, France

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