Prevention of Delirium in ICU Using Multimodal Interventions

NCT05950958 | Recruiting DMC

• 1 other identifier: Delirium_ICU
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Delirium

Keywords

Delirium; Intensive Care Unit; Non-pharmacological intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Delirium-free days

  From ICU admission up to day 28 or discharge from ICU or death

• Severity of delirium

  From ICU admission up to day 28 or discharge from ICU or death

• Accidental extubation or disconnection of treatment devices

  From ICU admission up to day 28 or discharge from ICU or death

• ICU and hospital length of stay

  From ICU admission up to day 28 or discharge from ICU or death

Study Arms (2)

Multimodal therapy group

EXPERIMENTAL

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

Conventional care group

NO INTERVENTION

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.

Interventions

Multimodal therapy for prevention of delirium OTHER

Multimodal therapy for prevention of delirium

Multimodal therapy group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 50 years who are expected to spend more than 24 hours in the intensive care unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ho Geol Ryu, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Leerang Lim, MD

CONTACT

+82-2-2072-2469; erange@snu.ac.kr

Ho Geol Ryu, MD, PhD

CONTACT

+82-2-2072-2065; hogeol@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: July 18, 2023
• Study Start: August 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)