PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Agitation,Psychomotor
- Sponsor
- Radboud University Medical Center
- Enrollment
- 480
- Locations
- 5
- Primary Endpoint
- ICU-free days
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ICU-free days
Time Frame: 28 days
Secondary Outcomes
- Hospital length of stay in days(up to 180 days)
- Days with delirium(14 days)
- Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention(14 days)
- Days with propofol (and total administered dose)(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)
- Days with coma(14 days)
- Duration of mechanical ventilation in days(up to 180 days)
- Incidence rate of (self-extubation induced) reintubations(14 days)
- Incidence rate of accidentally removed medical devices(14 days)
- Cognitive outcome(at 3, 12 and 24 months)
- Quality of life(at ICU admission, 3, 12 and 24 months)
- Days with dexmedetomidine (and total administered dose)(14 days)
- Physical outcome(at ICU admission, 3, 12 and 24 months)
- Mental outcome(at ICU admission 3, 12 and 24 months)
- Cost-effectiveness(12 months)