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

Last updated: April 29, 2024
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Manic Disorders

Treatment

Multicomponent intervention program

Clinical Study ID

NCT05783505
2022-16133
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ICUadmission

Exclusion

Exclusion criteria:

  • Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless apacemaker is present, uncontrolled hypotension, acute cerebrovascular condition orknown/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 tumorcausing 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.

Study Design

Total Participants: 480
Treatment Group(s): 1
Primary Treatment: Multicomponent intervention program
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
June 01, 2025

Study Description

Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is 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 on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.

Connect with a study center

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Active - Recruiting

  • Bravis Ziekenhuis

    Bergen Op Zoom,
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhuis

    Breda,
    Netherlands

    Active - Recruiting

  • Zuyderland Ziekenhuis

    Heerlen,
    Netherlands

    Site Not Available

  • Elkerliek Ziekenhuis

    Helmond,
    Netherlands

    Active - Recruiting

  • VieCuri Medisch Centrum

    Venlo,
    Netherlands

    Active - Recruiting

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