A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

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

480 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Radboud University Medical Center

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator