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.
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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
RECRUITINGBravis Ziekenhuis
Bergen op Zoom, Netherlands
RECRUITINGAmphia Ziekenhuis
Breda, Netherlands
RECRUITINGElkerliek Ziekenhuis
Helmond, Netherlands
RECRUITINGVieCuri Medisch Centrum
Venlo, Netherlands
RECRUITINGICU-free days
Time frame: 28 days
Incidence rate of accidentally removed medical devices
Time frame: 14 days
Incidence rate of (self-extubation induced) reintubations
Time frame: 14 days
Days with delirium
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)
Time frame: 14 days
Days with coma
Assessed using the Richmond Agitation and Sedation Scale (RASS)
Time frame: 14 days
Number of delirium- and coma-free days
Time frame: 14 days
Days with physical restraints
Time frame: 14 days
Days with dexmedetomidine (and total administered dose)
Time frame: 14 days
Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
Time frame: 14 days
Days with propofol (and total administered dose)
Time frame: 14 days
Duration of mechanical ventilation in days
Time frame: up to 180 days
Hospital length of stay in days
Time frame: up to 180 days
Mortality
Time frame: at 28 days, 3 months and 12 months
Physical outcome
E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires
Time frame: at ICU admission, 3, 12 and 24 months
Mental outcome
E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires
Time frame: at ICU admission 3, 12 and 24 months
Cognitive outcome
E.g., cognitive impairment, assessed using a validated questionnaire
Time frame: at 3, 12 and 24 months
Quality of life
Assessed using a validated QoL questionnaire
Time frame: at ICU admission, 3, 12 and 24 months
Cost-effectiveness
Measured by cost per Quality-Adjusted Life Year (QALY)
Time frame: 12 months
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