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

Not Applicable

Recruiting

• Conditions: Agitation,Psychomotor

• Registration Number: NCT05783505
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is 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 on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.

Study Timeline

• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-24
• Study Start: 2023-06-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ICU-free days	28 days

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay in days	up to 180 days
Days with delirium	14 days	Assessed using the Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the ICU (CAM-ICU), or the Delirium Observation Screening scale for the ward (DOS)
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention	14 days
Mortality	at 28 days, 3 months and 12 months
Number of delirium- and coma-free days	14 days
Days with physical restraints	14 days
Duration of mechanical ventilation in days	up to 180 days
Incidence rate of accidentally removed medical devices	14 days
Days with coma	14 days	Assessed using the Richmond Agitation and Sedation Scale (RASS)
Cognitive outcome	at 3, 12 and 24 months	E.g., cognitive impairment, assessed using a validated questionnaire
Quality of life	at ICU admission, 3, 12 and 24 months	Assessed using a validated QoL questionnaire
Incidence rate of (self-extubation induced) reintubations	14 days
Days with dexmedetomidine (and total administered dose)	14 days
Physical outcome	at ICU admission, 3, 12 and 24 months	E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Mental outcome	at ICU admission 3, 12 and 24 months	E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Cost-effectiveness	12 months	Measured by cost per Quality-Adjusted Life Year (QALY)
Days with propofol (and total administered dose)	14 days

Trial Locations

Locations (5)

Noordwest Ziekenhuisgroep; 🇳🇱 Alkmaar, Netherlands

Bravis Ziekenhuis; 🇳🇱 Bergen Op Zoom, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Elkerliek Ziekenhuis; 🇳🇱 Helmond, Netherlands

VieCuri Medisch Centrum; 🇳🇱 Venlo, Netherlands