Environmental Intervention on Delirious Patients

Delirium Clinical Trial

Official title:

The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042649
• Other study ID #: AsanMC-Delirium
• Status: Completed
• Phase: N/A
• Start date: June 1, 2013
• Est. completion date: October 31, 2014

Study information

• Verified date: August 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Behavioral:
• environmental intervention
provide environmental intervention (help sleep cycle, provide comfortable environment)

Locations

Country	Name	City	State
Korea, Republic of	Hakjae Lee	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence rate of delirium		5 month
Primary	time to delirium onset		5 month
Primary	the duration of delirium		5 month
Secondary	the number of days of ventilator use		5 month
Secondary	the length of stay at the SICU		5 month
Secondary	the length of stay at hospital		5 month
Secondary	the rate of re-admission to the SICU		5 month
Secondary	mortality rate.		5 month