Clinical trial NCT05783505: A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Official title: PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Agitation,Psychomotor
Keywords: ICU
Agitation
Physical Restraints
Non-pharmacologic interventions
Dexmedetomidine
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-03-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter stepped wedge cluster randomized controlled trial
Primary purpose: TREATMENT

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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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.

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.

Primary outcomes:
measure: ICU-free days
timeFrame: 28 days
Secondary outcomes:
measure: Incidence rate of accidentally removed medical devices
timeFrame: 14 days
measure: Incidence rate of (self-extubation induced) reintubations
timeFrame: 14 days
measure: Days with delirium
timeFrame: 14 days
measure: Days with coma
timeFrame: 14 days
measure: Number of delirium- and coma-free days
timeFrame: 14 days
measure: Days with physical restraints
timeFrame: 14 days
measure: Days with dexmedetomidine (and total administered dose)
timeFrame: 14 days
measure: Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention
timeFrame: 14 days
measure: Days with propofol (and total administered dose)
timeFrame: 14 days
measure: Duration of mechanical ventilation in days
timeFrame: up to 180 days
measure: Hospital length of stay in days
timeFrame: up to 180 days
measure: Mortality
timeFrame: at 28 days, 3 months and 12 months
measure: Physical outcome
timeFrame: at ICU admission, 3, 12 and 24 months
measure: Mental outcome
timeFrame: at ICU admission 3, 12 and 24 months
measure: Cognitive outcome
timeFrame: at 3, 12 and 24 months
measure: Quality of life
timeFrame: at ICU admission, 3, 12 and 24 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
measure: Incidence rate of falls out of bed
timeFrame: 14 days
measure: A secondary Bayesian analysis of the trial including heterogeneity of treatment effect
timeFrame: To be conducted within one year after study completion
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Bergen Op Zoom
country: Netherlands
facility: Bravis Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
Study officials:
affiliation: Radboud University Medical Center
name: Bram Tilburgs, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Mark van den Boogaard, PhD
role: STUDY_DIRECTOR
References: