Prevention of Delirium in ICU Using Multimodal Interventions

Intensive Care Unit Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950958
• Other study ID #: Delirium_ICU
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: Leerang Lim, MD
• Phone: +82-2-2072-2469
• Email: erange[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Delirium

Intervention

Other:
• Multimodal therapy for prevention of delirium
Multimodal therapy for prevention of delirium

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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