Environmental Intervention on Delirious Patients

Not Applicable

Completed

• Conditions: Delirium
• Interventions: Behavioral: environmental intervention

• Registration Number: NCT04042649
• Lead Sponsor: Asan Medical Center

Brief Summary

The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.

Detailed Description

Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.

Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• with an age of 18 years or older
• who understood the purpose of this study and agreed to participate
• stayed in the SICU for a period of 48 hours or longer

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Exclusion Criteria

• who remained unresponsive [defined as the Richmond Agitation-Sedation Scale (RASS) less than -4]
• who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
• who had a history of severe psychiatric or neurologic deficit
• who required an isolation room due to transplantation or immunologic compromise
• who were discharged from ICU within 48 hours
• who were re-admitted to the ICU
• who were less than 18 years old
• who were admitted to the Surgical ICU through another ICU

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
post-intervention	environmental intervention	After providing environmental intervention for critically ill patients

Primary Outcome Measures

Name	Time	Method
the incidence rate of delirium	5 month
time to delirium onset	5 month
the duration of delirium	5 month

Secondary Outcome Measures

Name	Time	Method
the length of stay at the SICU	5 month
the number of days of ventilator use	5 month
the rate of re-admission to the SICU	5 month
mortality rate.	5 month
the length of stay at hospital	5 month

Trial Locations

Locations (1)

Hakjae Lee; 🇰🇷 Seoul, Korea, Republic of