Actively Recruiting
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Led by Radboud University Medical Center · Updated on 2025-06-17
480
Participants Needed
5
Research Sites
174 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult ICU patients (aged 6518) with an expected ICU stay of more than 24 hours
- Patients who are (expected to become) agitated within the first 14 days of their ICU admission
You will not qualify if you...
- Contraindication for dexmedetomidine use (e.g., 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
- Intoxication from drug abuse such as ethanol, b3-Hydroxybutyrate, opioids, or benzodiazepines
- Support with Extracorporeal Membrane Oxygenation (ECMO)
- Difficult airway (e.g., Cormack and Lehane laryngoscopy grade 4 view or tumor causing airway obstruction)
- High risk of physical aggression towards healthcare professionals
- No consent for long term follow up in the MONITOR-IC study
- Unable to read or understand the Dutch language and no relatives able to assist
- Enrolment in other sedation studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Actively Recruiting
2
Bravis Ziekenhuis
Bergen op Zoom, Netherlands
Actively Recruiting
3
Amphia Ziekenhuis
Breda, Netherlands
Actively Recruiting
4
Elkerliek Ziekenhuis
Helmond, Netherlands
Actively Recruiting
5
VieCuri Medisch Centrum
Venlo, Netherlands
Actively Recruiting
Research Team
R
Rens Kooken, MSc
CONTACT
B
Bram Tilburgs, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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