About this trial
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.
Eligibility criteria
Qualifiers
Adult ICU patients (aged ≥18) with an expected ICU stay of >24 hours
Patients who are (expected to become) agitated within the first 14 days of their ICU admission
Disqualifiers
Contra indication for dexmedetomidine use (i.e., 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;
An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);
Support with Extracorporeal Membrane Oxygenation (ECMO);
Trial design
Treatments tested in this trial
- Multicomponent intervention program
Treatment groups
Sponsors and collaborators
Radboud University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator