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NCT Number: NCT05783505

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Noordwest Ziekenhuisgroep, Alkmaar, Netherlands

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About this study

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restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multicomponent intervention program

Other

Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed

Primary outcomes

  1. ICU-free days

    Time frame: 28 days

Secondary outcomes

  1. Incidence rate of accidentally removed medical devices

    Time frame: 14 days

  2. Incidence rate of (self-extubation induced) reintubations

    Time frame: 14 days

  3. Days with delirium

    Time frame: 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)

  4. Days with coma

    Time frame: 14 days

    Assessed using the Richmond Agitation and Sedation Scale (RASS)

  5. Number of delirium- and coma-free days

    Time frame: 14 days

  6. Days with physical restraints

    Time frame: 14 days

  7. Days with dexmedetomidine (and total administered dose)

    Time frame: 14 days

  8. Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention

    Time frame: 14 days

  9. Days with propofol (and total administered dose)

    Time frame: 14 days

  10. Duration of mechanical ventilation in days

    Time frame: up to 180 days

  11. Hospital length of stay in days

    Time frame: up to 180 days

  12. Mortality

    Time frame: at 28 days, 3 months and 12 months

  13. Physical outcome

    Time frame: at ICU admission, 3, 12 and 24 months

    E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires

  14. Mental outcome

    Time frame: at ICU admission 3, 12 and 24 months

    E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires

  15. Cognitive outcome

    Time frame: at 3, 12 and 24 months

    E.g., cognitive impairment, assessed using a validated questionnaire

  16. Quality of life

    Time frame: at ICU admission, 3, 12 and 24 months

    Assessed using a validated QoL questionnaire

  17. Cost-effectiveness

    Time frame: 12 months

    Measured by cost per Quality-Adjusted Life Year (QALY)

Other outcomes

  1. Incidence rate of falls out of bed

    Time frame: 14 days

  2. A secondary Bayesian analysis of the trial including heterogeneity of treatment effect

    Time frame: To be conducted within one year after study completion

    A secondary Bayesian analysis of the trial including heterogeneity of treatment effect

Study contacts

Contact information is provided by the study sponsor or research team.

Bram Tilburgs, PhD

CONTACT

[email protected]

+31 24 361 4996

Rens Kooken, MSc

CONTACT

[email protected]

+31 24 361 6735

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention

Acronym: PRAISE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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