Program to reduce ICU agitation and use of physical restraints

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a person-centered multicomponent intervention (MCI) program designed to prevent and reduce agitation in adult ICU patients. The program combines non-pharmacological interventions with goal-directed light sedation using dexmedetomidine, aiming to improve patient outcomes compared to the traditional use of physical restraints. The effectiveness of this approach will be assessed in terms of both short- and long-term outcomes, as well as healthcare costs associated with ICU care. The study focuses on patients who are expected to become agitated during their ICU stay, addressing a significant issue in critical care settings.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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

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, 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's running

• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Recruiting
• Bravis Ziekenhuis
  Bergen op Zoom, Netherlands Recruiting
• Amphia Ziekenhuis
  Breda, Netherlands Recruiting
• Elkerliek Ziekenhuis
  Helmond, Netherlands Recruiting
• VieCuri Medisch Centrum
  Venlo, Netherlands Recruiting

Study contacts

• Principal investigator: Bram Tilburgs, PhD — Radboud University Medical Center
• Study coordinator: Rens Kooken, MSc
• Email: rens.kooken@radboudumc.nl
• Phone: +31 24 361 6735

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.