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NCT Number: NCT05950958

Prevention of Delirium in ICU Using Multimodal Interventions

This study was designed to evaluate the impact of non-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Delirium significantly increases not only the length of the intensive care unit stay and overall mortality, but also the likelihood of persistant cognitive impairment after recovery. However there is no definitive treatment for delirium, thereby it is important to prevent delirium before it occur. Researches also have focused on the prevention of delirium or the reduction of duration of delirium.

Several studies evaluated the effect of non-pharmacological treatment, such as improvement of orientation, prevention of sensory deprivation, active pain control and prevention of dehydration, to reduce the occurrence of delirium and the results were inconsistent depending on the patients included. However, there have been no randomized clinical trials that have tested the effect of prevention of delirium by applying non-pharmacological multimodal approaches in the intensive care unit for Korean patients.

A randomized controlled trial was planned to evaluate the impact of on-pharmacological multimodal interventions including ongoing orientation, sensory correction, setting of familiar circumstance and promotion of sleep enviromnet for prevention of delirium in intensive care unit in Korea.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit

Exclusion criteria

  • Patients who developed delirium before entering the intensive care unit
  • Patients with cognitive impairment
  • Patients who have hearing or vision deficits, or have difficulty in communication
  • Patients who are expected to die within 24 hours or do not want life-sustaining treatment

Treatment and study plan

Multimodal therapy for prevention of delirium

Other

Multimodal therapy for prevention of delirium

Primary outcomes

  1. Number of patients with delirium

    Time frame: From ICU admission up to day 28 or discharge from ICU or death

    Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)

Secondary outcomes

  1. Delirium-free days

    Time frame: From ICU admission up to day 28 or discharge from ICU or death

    Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)

  2. Severity of delirium

    Time frame: From ICU admission up to day 28 or discharge from ICU or death

    Confusion Assessment Method for the ICU-7 (CAM-ICU-7) delirium severity score

  3. Accidental extubation or disconnection of treatment devices

    Time frame: From ICU admission up to day 28 or discharge from ICU or death

    Accidental extubation or disconnection of treatment devices

  4. ICU and hospital length of stay

    Time frame: From ICU admission up to day 28 or discharge from ICU or death

    Duration of ICU and hospital stay

Study contacts

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

Ho Geol Ryu, MD, PhD

CONTACT

[email protected]

+82-2-2072-2065

Leerang Lim, MD

CONTACT

[email protected]

+82-2-2072-2469

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Impact of Audio and Visual Intervention in Preventing ICU Delirium in Critically Ill Patients : A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jul 18, 2023
Registry last updated
Jun 2, 2026

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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