Program to reduce ICU agitation and use of physical restraints

PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention

This study is testing a new program to help calm agitated adults in the ICU without using physical restraints, to see if it improves their care and reduces costs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (Academic / other)
• Locations: 5 sites (Alkmaar and 4 other locations)
• Trial ID: NCT05783505 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adult ICU patients aged 18 and older who are expected to stay in the ICU for more than 24 hours and may become agitated within the first 14 days of admission.

Not a fit: Patients with contraindications for dexmedetomidine use or those at high risk of physical aggression towards healthcare professionals may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of care for ICU patients by reducing the need for physical restraints and enhancing patient comfort.

How similar studies have performed: Other studies have shown promising results with non-pharmacological interventions in ICU settings, suggesting that this approach may be effective, though the specific combination being tested here is novel.

Eligibility criteria

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 this trial is running

Alkmaar and 4 other locations

• 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

Conditions Agitation,Psychomotor; ICU; Agitation; Physical Restraints; Non-pharmacologic interventions; Dexmedetomidine