Agitation,Psychomotor
Conditions
Keywords
ICU, Agitation, Physical Restraints, Non-pharmacologic interventions, Dexmedetomidine
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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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.
Interventions
OTHERMulticomponent intervention program
Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed
Sponsors
Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter stepped wedge cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU-free days | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of accidentally removed medical devices | 14 days | — |
| Incidence rate of (self-extubation induced) reintubations | 14 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) |
| Days with coma | 14 days | Assessed using the Richmond Agitation and Sedation Scale (RASS) |
| Number of delirium- and coma-free days | 14 days | — |
| Days with physical restraints | 14 days | — |
| Days with dexmedetomidine (and total administered dose) | 14 days | — |
| Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention | 14 days | — |
| Days with propofol (and total administered dose) | 14 days | — |
| Duration of mechanical ventilation in days | up to 180 days | — |
| Hospital length of stay in days | up to 180 days | — |
| Mortality | at 28 days, 3 months and 12 months | — |
| 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 |
| 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 |
| Cost-effectiveness | 12 months | Measured by cost per Quality-Adjusted Life Year (QALY) |
Countries
Netherlands
Contacts
CONTACTRens Kooken, MSc
CONTACTBram Tilburgs, PhD
PRINCIPAL_INVESTIGATORBram Tilburgs, PhD
Radboud University Medical Center
STUDY_DIRECTORMark van den Boogaard, PhD
Radboud University Medical Center
Outcome results
None listed