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Rethinking ICU care: could a personalized plan replace physical restraints?

NCT ID NCT05783505

Disease control Sponsor: Radboud University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests a person-centered care program for adult ICU patients who are or may become agitated. The program combines non-drug calming strategies with light sedation using dexmedetomidine when needed, aiming to reduce the use of physical restraints. Researchers will compare this approach to standard care, measuring outcomes like time spent outside the ICU and accidental removal of medical devices.

What this could mean

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

Active substance
A multicomponent intervention program combining non-pharmacological approaches with goal-directed sedation using dexmedetomidine when needed
What this could lead to
If effective, this approach could reduce the need for physical restraints in ICU patients, potentially lowering complications and improving patient safety and comfort.
What could go wrong
The trial is early and the intervention is complex, so results may not be conclusive or widely applicable. Dexmedetomidine has risks like low blood pressure or slow heart rate.

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

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

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: * Adult ICU patients (aged ≥18) with an expected ICU stay of \>24 hours * Patients who are (expected to become) agitated within the first 14 days of their ICU admission Exclusion criteria: * Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity); * Neurological patients with an (expected risk of) increased intracranial pressure; * An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines); * Support with Extracorporeal Membrane Oxygenation (ECMO); * Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction); * A high risk of physical aggression towards healthcare professionals; * No consent for long term follow up in the MONITOR-IC study; * Not able to read or understand the Dutch language and no relatives able to assist; * Enrolment in other sedation studies.

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Conditions

The condition(s) this trial relates to.

Psychomotor Agitation

As listed by the trial registrant

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

Agitation,psychomotor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amphia Ziekenhuis

    RECRUITING

    Breda, Netherlands

  • Bravis Ziekenhuis

    RECRUITING

    Bergen op Zoom, Netherlands

  • Elkerliek Ziekenhuis

    RECRUITING

    Helmond, Netherlands

  • Noordwest Ziekenhuisgroep

    RECRUITING

    Alkmaar, Netherlands

  • VieCuri Medisch Centrum

    RECRUITING

    Venlo, Netherlands

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