RecruitingNot ApplicableNCT05783505

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

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

Sponsor

Radboud University Medical Center

Enrollment

480 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Agitation,Psychomotor

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria9

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.