Prevention of Delirium in ICU Using Multimodal Interventions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intensive Care Unit Delirium

Intervention / Treatment
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* Other: Multimodal therapy for prevention of delirium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal therapy group<br>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<br>* Multimodal therapy for prevention of delirium<br>|
| No Intervention: Conventional care group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Intensive Care Unit, Non-pharmacological intervention