An interventional study of Multimodal therapy for prevention of delirium in Intensive Care Unit Delirium, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 196 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
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
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.
Multimodal therapy for prevention of delirium
Number of patients with delirium
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: From ICU admission up to day 28 or discharge from ICU or death
Delirium-free days
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From ICU admission up to day 28 or discharge from ICU or death
Plan to share: No
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