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Guiding the use of physical restraints in ICU patients

Impact of a Decision-making Tool to Guide the Use of Physical Restraints in Intensive Care Unit Patients. A Multicentre Randomized Stepped-wedge Trial.

Not applicable Interventional University Hospital, Clermont-Ferrand · NCT04957238

This study is testing a new tool to help doctors decide when to use physical restraints on ICU patients to improve their safety and care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment4000 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Clermont-Ferrand Academic / other
Locations20 sites (Aurillac and 19 other locations)
Trial IDNCT04957238 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a decision-making tool designed to guide the use of physical restraints in Intensive Care Unit (ICU) patients. The tool incorporates objective criteria, including the Richmond Agitation-Sedation Scale (RASS) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), to reduce the subjectivity in the decision-making process. By assessing patients' neurological status and other factors, the study seeks to improve patient safety and care in the ICU setting. The intervention will be implemented in multiple hospitals to gather diverse data on its impact.

Who should consider this trial

Good fit: Ideal candidates include adult patients over 18 years old who have been hospitalized in the ICU for at least 48 hours.

Not a fit: Patients who are expected to remain under deep sedation throughout their ICU stay may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance patient safety and reduce unnecessary physical restraint use in critically ill patients.

How similar studies have performed: While the use of decision-making tools in clinical settings is common, this specific approach to guiding physical restraint use in ICU patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Aurillac and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Critically IllIntensive Care Unit DeliriumDelirium Confusional StateAgitation,PsychomotorICUPhysical restraintsSafetyAgitation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.