NCT05783505 · RECRUITING
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
This trial is testing a care program designed to reduce the use of physical restraints in ICU patients who become agitated. The program combines non-drug calming techniques with a light sedation medication called dexmedetomidine, comparing it to standard ICU care that typically includes physical restraints. This is a Phase NA trial, meaning it is evaluating a care practice rather than a new drug, and is being conducted in Dutch ICUs.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-06-17