Environmental Intervention on Delirious Patients

NCT ID: NCT04042649

Last Updated: 2019-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-01

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Delirium

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pre-intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

post-intervention

After providing environmental intervention for critically ill patients

Group Type EXPERIMENTAL

environmental intervention

Intervention Type BEHAVIORAL

provide environmental intervention (help sleep cycle, provide comfortable environment)

Interventions

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environmental intervention

provide environmental intervention (help sleep cycle, provide comfortable environment)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Suk-Kyung

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hakjae Lee

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 8092177 (View on PubMed)

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.

Reference Type RESULT
PMID: 23978407 (View on PubMed)

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.

Reference Type RESULT
PMID: 15082703 (View on PubMed)

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.

Reference Type RESULT
PMID: 23317943 (View on PubMed)

Other Identifiers

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AsanMC-Delirium

Identifier Type: -

Identifier Source: org_study_id

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