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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ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adult ICU patients aged 18 years or older
Expected ICU stay of more than 24 hours
Patients who are agitated or expected to become agitated within the first 14 days of ICU admission
You will not qualify if you...
Contraindications for dexmedetomidine use, such as second or third-degree AV block without a pacemaker, uncontrolled low blood pressure, acute cerebrovascular conditions, or known/suspected hypersensitivity
Neurological patients with an expected risk of increased intracranial pressure
Intoxication due to drug abuse (e.g., ethanol, gamma-Hydroxybutyrate, opioids, benzodiazepines)
Support with Extracorporeal Membrane Oxygenation (ECMO)
Difficult airway conditions, such as severe airway obstruction or poor laryngoscopy view
High risk of physical aggression towards healthcare professionals
Lack of consent for long term follow-up in the MONITOR-IC study
Inability to read or understand Dutch without relatives able to assist
Participation in other sedation studies
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
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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Published Research Related To This Trial
A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial.