A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Recruiting now · Not applicable
Conditions studied: Agitation,Psychomotor
In brief
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.
Key facts
- Study ID
- NCT05783505
- Run by
- Radboud University Medical Center
- People needed
- 480
- Starts
- 2023-06-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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);
- Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);
- A high risk of physical aggression towards healthcare professionals;
- No consent for long term follow up in the MONITOR-IC study;
- Not able to read or understand the Dutch language and no relatives able to assist;
- Enrolment in other sedation studies.
Where it is running
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (enrolling)
- Bravis Ziekenhuis — Bergen op Zoom, Netherlands (enrolling)
- Amphia Ziekenhuis — Breda, Netherlands (enrolling)
- Elkerliek Ziekenhuis — Helmond, Netherlands (enrolling)
- VieCuri Medisch Centrum — Venlo, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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