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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05950958
Enrollment
196
Registered
2023-07-18
Start date
2022-08-01
Completion date
2028-07-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Delirium

Keywords

Delirium, Intensive Care Unit, Non-pharmacological intervention

Brief summary

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

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.

Interventions

OTHERMultimodal therapy for prevention of delirium

Multimodal therapy for prevention of delirium

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with deliriumFrom ICU admission up to day 28 or discharge from ICU or deathDelirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)

Secondary

MeasureTime frameDescription
Delirium-free daysFrom ICU admission up to day 28 or discharge from ICU or deathDelirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
Severity of deliriumFrom ICU admission up to day 28 or discharge from ICU or deathConfusion Assessment Method for the ICU-7 (CAM-ICU-7) delirium severity score
Accidental extubation or disconnection of treatment devicesFrom ICU admission up to day 28 or discharge from ICU or deathAccidental extubation or disconnection of treatment devices
ICU and hospital length of stayFrom ICU admission up to day 28 or discharge from ICU or deathDuration of ICU and hospital stay

Countries

South Korea

Contacts

CONTACTLeerang Lim, MD
erange@snu.ac.kr+82-2-2072-2469
CONTACTHo Geol Ryu, MD, PhD
hogeol@gmail.com+82-2-2072-2065
STUDY_CHAIRHo Geol Ryu, MD, PhD

Seoul National University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026