Actively Recruiting
Led by Radboud University Medical Center · Updated on 2025-06-17
480
Participants Needed
5
Research Sites
52 weeks
Total Duration
R
Radboud University Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
Researchers are evaluating a person-centered multicomponent intervention program to prevent and reduce agitation and the use of physical restraints in adult patients in intensive care units (ICUs). This program combines non-drug approaches with light sedation guided by the drug dexmedetomidine. The study aims to compare this approach with the usual care that includes physical restraints, focusing on both short- and long-term patient outcomes and healthcare costs. The study involves two groups: one receiving the multicomponent intervention program, which uses non-pharmacological methods combined with goal-directed light sedation using dexmedetomidine when needed, and the other receiving standard care that may include physical restraints. The intervention is designed for adult ICU patients who are agitated or expected to become agitated during their ICU stay. Participants will be monitored for various outcomes including ICU-free days within 28 days, rates of device removal, reintubations, days with delirium or coma, use of physical restraints and sedative drugs, duration of mechanical ventilation, hospital stay length, mortality at multiple time points, as well as physical, mental, cognitive outcomes and quality of life up to 24 months. Safety and cost-effectiveness will also be evaluated. The total follow-up may extend up to one year or more, with detailed assessments at several time points.
CONDITIONS
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days during ICU stay
Participants receive a multicomponent intervention program combining non-pharmacological interventions with goal-directed light sedation using dexmedetomidine if needed, or standard care during their ICU stay.
Daily assessments during ICU stay for up to 14 days
Duration - Up to 24 months after ICU admission
Participants are monitored for long-term outcomes including physical, mental, cognitive health, quality of life, and mortality up to 24 months after ICU admission.
Assessments at ICU admission, 3, 12, and 24 months; mortality follow-up at 28 days, 3 months, and 12 months
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
R
Rens Kooken, MSc
B
Bram Tilburgs, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Rens W J Kooken, Bram Tilburgs, Rob Ter Heine...
https://pubmed.ncbi.nlm.nih.gov/38082351