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.
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
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);
Parallel
Multicomponent intervention program
Other interventionNon-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
ICU-free days
Incidence rate of accidentally removed medical devices
Incidence rate of (self-extubation induced) reintubations
Days with delirium
Assessed using the Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the ICU (CAM-ICU), or the Delirium Observation Screening scale for the ward (DOS)
Days with coma
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Incidence rate of falls out of bed
A secondary Bayesian analysis of the trial including heterogeneity of treatment effect
A secondary Bayesian analysis of the trial including heterogeneity of treatment effect
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Radboud University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
