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

RecruitingNAAges 18 Years - anyAllRadboud University Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: * Adult ICU patients (aged โ‰ฅ18) with an expected ICU stay of \>24 hours * Patients who are (expected to become) agitated within the first 14 days of their ICU admission Exclusion criteria: * 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, ฮณ-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.
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What it tests

  • Multicomponent intervention program
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Where

5 sites
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Bravis Ziekenhuis
Bergen op Zoom, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
VieCuri Medisch Centrum
Venlo, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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