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

NCT05783505 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-08-20

No results posted yet for this 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.

Conditions

  • Agitation,Psychomotor

Interventions

OTHER

Multicomponent intervention program

Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Bram Tilburgs, PhD · Radboud University Medical Center

  • Mark van den Boogaard, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-10-01
Completion
2026-10-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783505 on ClinicalTrials.gov