Clinical trial NCT05950958: Prevention of Delirium in ICU Using Multimodal Interventions
Official title: The Impact of Audio and Visual Intervention in Preventing ICU Delirium in Critically Ill Patients : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intensive Care Unit Delirium
Keywords: Delirium
Intensive Care Unit
Non-pharmacological intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 196
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with delirium
timeFrame: From ICU admission up to day 28 or discharge from ICU or death
Secondary outcomes:
measure: Delirium-free days
timeFrame: From ICU admission up to day 28 or discharge from ICU or death
measure: Severity of delirium
timeFrame: From ICU admission up to day 28 or discharge from ICU or death
measure: Accidental extubation or disconnection of treatment devices
timeFrame: From ICU admission up to day 28 or discharge from ICU or death
measure: ICU and hospital length of stay
timeFrame: From ICU admission up to day 28 or discharge from ICU or death
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ho Geol Ryu, MD, PhD
role: STUDY_CHAIR
References: