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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Mar 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help manage agitation in patients who are in the Intensive Care Unit (ICU). Agitation can be distressing and often leads to the use of physical restraints, which can have negative effects on patients. The trial aims to test a person-centered program that combines non-drug methods with a gentle medication called dexmedetomidine to see if it can reduce agitation and the need for restraints compared to the traditional methods currently used in Dutch ICUs.

To participate in this study, patients must be adults aged 18 and older who are expected to stay in the ICU for more than 24 hours and may become agitated within the first two weeks of their admission. However, certain patients cannot join, such as those with specific heart issues, certain neurological conditions, or those who are intoxicated. If eligible, participants can expect to receive care from a team focused on their individual needs and comfort, while helping researchers understand the best ways to manage agitation in ICU settings.

Gender

ALL

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.