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Environmental Intervention on Delirious Patients

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
environmental intervention
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring intensive care unit, critically ill patients, environmental intervention

Eligibility Criteria

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

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

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

Sites / Locations

  • Hakjae Lee

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

pre-intervention

post-intervention

Arm Description

Critically ill patients didn't provide environmental intervention (help sleep cycle, provide comfortable environment)

After providing environmental intervention for critically ill patients

Outcomes

Primary Outcome Measures

the incidence rate of delirium
time to delirium onset
the duration of delirium

Secondary Outcome Measures

the number of days of ventilator use
the length of stay at the SICU
the length of stay at hospital
the rate of re-admission to the SICU
mortality rate.

Full Information

First Posted
July 31, 2019
Last Updated
August 1, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04042649
Brief Title
Environmental Intervention on Delirious Patients
Official Title
The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2013 (Actual)
Primary Completion Date
October 31, 2014 (Actual)
Study Completion Date
October 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
intensive care unit, critically ill patients, environmental intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre-intervention
Arm Type
No Intervention
Arm Description
Critically ill patients didn't provide environmental intervention (help sleep cycle, provide comfortable environment)
Arm Title
post-intervention
Arm Type
Experimental
Arm Description
After providing environmental intervention for critically ill patients
Intervention Type
Behavioral
Intervention Name(s)
environmental intervention
Intervention Description
provide environmental intervention (help sleep cycle, provide comfortable environment)
Primary Outcome Measure Information:
Title
the incidence rate of delirium
Time Frame
5 month
Title
time to delirium onset
Time Frame
5 month
Title
the duration of delirium
Time Frame
5 month
Secondary Outcome Measure Information:
Title
the number of days of ventilator use
Time Frame
5 month
Title
the length of stay at the SICU
Time Frame
5 month
Title
the length of stay at hospital
Time Frame
5 month
Title
the rate of re-admission to the SICU
Time Frame
5 month
Title
mortality rate.
Time Frame
5 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
Hakjae Lee
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8092177
Citation
Inouye SK. The dilemma of delirium: clinical and research controversies regarding diagnosis and evaluation of delirium in hospitalized elderly medical patients. Am J Med. 1994 Sep;97(3):278-88. doi: 10.1016/0002-9343(94)90011-6.
Results Reference
result
PubMed Identifier
23978407
Citation
Holt R, Young J, Heseltine D. Effectiveness of a multi-component intervention to reduce delirium incidence in elderly care wards. Age Ageing. 2013 Nov;42(6):721-7. doi: 10.1093/ageing/aft120. Epub 2013 Aug 26.
Results Reference
result
PubMed Identifier
15082703
Citation
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
Results Reference
result
PubMed Identifier
23317943
Citation
Arenson BG, MacDonald LA, Grocott HP, Hiebert BM, Arora RC. Effect of intensive care unit environment on in-hospital delirium after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Jul;146(1):172-8. doi: 10.1016/j.jtcvs.2012.12.042. Epub 2013 Jan 11.
Results Reference
result

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Environmental Intervention on Delirious Patients

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