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RECRUITING Not applicable ClinicalTrials.gov

A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use

Sponsor: Radboud University Medical Center • ClinicalTrials.gov ID: NCT05783505

Registry updated: 2026-08-20
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Description

Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.

Interventions

  • Multicomponent intervention program (Other)
    Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

Eligibility criteria

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.

Conditions

Agitation,Psychomotor

Locations

  • Noordwest Ziekenhuisgroep — Alkmaar, Netherlands
  • Bravis Ziekenhuis — Bergen op Zoom, Netherlands
  • Amphia Ziekenhuis — Breda, Netherlands
  • Elkerliek Ziekenhuis — Helmond, Netherlands
  • VieCuri Medisch Centrum — Venlo, Netherlands
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record