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Prevention of Delirium in ICU Using Multimodal Interventions

Primary Purpose

Intensive Care Unit Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multimodal therapy for prevention of delirium
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intensive Care Unit Delirium focused on measuring Delirium, Intensive Care Unit, Non-pharmacological intervention

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multimodal therapy group

Conventional care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of patients with delirium
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)

Secondary Outcome Measures

Delirium-free days
Delirium assessed by Confusion Assessment Method for the ICU (CAM-ICU)
Severity of delirium
Confusion Assessment Method for the ICU-7 (CAM-ICU-7) delirium severity score
Accidental extubation or disconnection of treatment devices
Accidental extubation or disconnection of treatment devices
ICU and hospital length of stay
Duration of ICU and hospital stay

Full Information

First Posted
July 28, 2022
Last Updated
July 10, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05950958
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Delirium
Keywords
Delirium, Intensive Care Unit, Non-pharmacological intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multimodal therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Multimodal therapy for prevention of delirium
Intervention Description
Multimodal therapy for prevention of delirium
Primary Outcome Measure Information:
Title
Number of patients with delirium
Description
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
Secondary Outcome Measure Information:
Title
Delirium-free days
Description
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
Title
Severity of delirium
Description
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
Title
Accidental extubation or disconnection of treatment devices
Description
Accidental extubation or disconnection of treatment devices
Time Frame
From ICU admission up to day 28 or discharge from ICU or death
Title
ICU and hospital length of stay
Description
Duration of ICU and hospital stay
Time Frame
From ICU admission up to day 28 or discharge from ICU or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leerang Lim, MD
Phone
+82-2-2072-2469
Email
erange@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Geol Ryu, MD, PhD
Phone
+82-2-2072-2065
Email
hogeol@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Geol Ryu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Geol Ryu, MD, PhD
Phone
+82-2072-2065
Email
hogeol@gmail.com
First Name & Middle Initial & Last Name & Degree
Seung-Young Oh, MD, MS
Phone
+82-2072-3098
Email
faun1226@gmail.com
First Name & Middle Initial & Last Name & Degree
Ho Geol Ryu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevention of Delirium in ICU Using Multimodal Interventions

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