Prevention of Delirium in ICU Using Multimodal Interventions

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit Delirium
• Intervention / Treatment: Other: Multimodal therapy for prevention of delirium

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ho Geol Ryu, MD, PhD; Phone Number: +82-2-2072-2065; Email: hogeol@gmail.com
• Study Contact Backup: Name: Leerang Lim, MD; Phone Number: +82-2-2072-2469; Email: erange@snu.ac.kr

Study Locations

• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ho Geol Ryu, MD, PhD; Phone Number: +82-2072-2065; Email: hogeol@gmail.com
    • Contact: Seung-Young Oh, MD, MS; Phone Number: +82-2072-3098; Email: faun1226@gmail.com
    • Principal Investigator: Ho Geol Ryu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimodal therapy group; Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored. Multimodal therapy with conventional care are provided to prevent delirium. Ongoing orientation: 3 times per day Sensory correction: the hearing device and the glasses are supplied. Cognitive stimulation: a portable monitor is used to provide visual stimulation, and a directional speaker is used to avoid disturbing the alarm of the patient's life supportimng system. Sleep promotion: the lights are turned off from 10 pm to 7 am, and the indirect light source is used if necessary.	Other: Multimodal therapy for prevention of delirium; Multimodal therapy for prevention of delirium
No Intervention: Conventional care group; Continuous regional cerebral oxygen saturation and processed electroencephalogram (EEG) are monitored. Conventional care: If sedation is required, dexmedetomidine is considered as the first-line sedative drug. The sedation is interrupted daily and the possibility of awakening is assessed. Pain with NRS score above 3, is controlled with opioid. For patients with Richmond Agitation Sedation Scale (RASS) -4 or -5, possible items are provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with delirium	Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)	From ICU admission up to day 28 or discharge from ICU or death

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium-free days	Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)	From ICU admission up to day 28 or discharge from ICU or death
Severity of delirium	Confusion Assessment Method for the ICU-7 (CAM-ICU-7) delirium severity score	From ICU admission up to day 28 or discharge from ICU or death
Accidental extubation or disconnection of treatment devices	Accidental extubation or disconnection of treatment devices	From ICU admission up to day 28 or discharge from ICU or death
ICU and hospital length of stay	Duration of ICU and hospital stay	From ICU admission up to day 28 or discharge from ICU or death

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Ho Geol Ryu, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Delirium; Non-pharmacological intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium; Therapeutics; Combined Modality Therapy
• Other Study ID Numbers: Delirium_ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No