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ICU restraint reduction may cut delirium days

NCT ID NCT04273360

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 423 adults on breathing machines in intensive care units (ICUs). Half were physically restrained only if severely agitated, while the other half were restrained routinely. Researchers measured how many days patients were free of delirium (confusion) over the first two weeks. The goal was to see if a more careful use of restraints could reduce delirium duration.

What this could mean

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

Active substance
physical restraint (wrist straps) used either systematically or restrictively
What this could lead to
If successful, this could show that using restraints less often reduces delirium in ICU patients, leading to better recovery and shorter hospital stays.
What could go wrong
This is a completed trial, but results may not apply to all ICUs or patient groups. The open-label design (no blinding) could bias outcomes.

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

423 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2025

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 : * 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 Exclusion criteria : Patients meeting one of the following criteria will not be considered for inclusion: * 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 or person of confidence (if present at the time of inclusion) opposing the patient's participation in research * Patient already involved in another interventional clinical research whose main objective is related to delirium

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As listed by the trial registrant

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

Mechanical ventilation Restraint, physical

Contacts and locations

Locations

  • Hôpital Bichat-Claude Bernard

    Paris, 75018, France

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