A Multicomponent Intervention Program to Prevent and Redu... | NCT05783505

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

NCT05783505

Sponsor

Radboud University Medical Center

Status

Recruiting

Last Update Posted

Jun 17, 2025Actual

Enrollment

480Estimated

Phase

Not Applicable

Conditions

Agitation,Psychomotor

Interventions

Multicomponent intervention program

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Jan 8, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Mar 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2025

Last Update Posted Date

Jun 17, 2025Actual

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Multicomponent intervention program	Other: Multicomponent intervention program
Control group	No Intervention	Standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multicomponent intervention program	Other	Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICU-free days		28 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence rate of accidentally removed medical devices		14 days
Incidence rate of (self-extubation induced) reintubations		14 days
Days with delirium

Other Outcomes

Measure	Description	Time Frame
Incidence rate of falls out of bed		14 days
A secondary Bayesian analysis of the trial including heterogeneity of treatment effect	A secondary Bayesian analysis of the trial including heterogeneity of treatment effect

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rens Kooken, MSc	Contact	+31 24 361 6735		rens.kooken@radboudumc.nl
Bram Tilburgs, PhD	Contact	+31 24 361 4996		bram.tilburgs@radboudumc.nl

Overall Officials

Name	Affiliation	Role
Bram Tilburgs, PhD	Radboud University Medical Center	Principal Investigator
Mark van den Boogaard, PhD	Radboud University Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Noordwest Ziekenhuisgroep	Recruiting	Alkmaar			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38082351	Derived	Kooken RWJ, Tilburgs B, Ter Heine R, Ramakers B, van den Boogaard M; PRAISE study group. A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial. Trials. 2023 Dec 11;24(1):800. doi: 10.1186/s13063-023-07807-x.

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D011596	Psychomotor Disorders