Actively Recruiting
Improving ICU Care for Agitated Adults Using a Multicomponent Program with Light Sedation and Non-Drug Methods
Led by Radboud University Medical Center · Updated on 2025-06-17
480
Participants Needed
5
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Research Team
R
Rens Kooken, MSc
B
Bram Tilburgs, PhD
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