Clinical trial NCT04042649: Environmental Intervention on Delirious Patients
Official title: The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: intensive care unit
critically ill patients
environmental intervention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the incidence rate of delirium
timeFrame: 5 month
measure: time to delirium onset
timeFrame: 5 month
measure: the duration of delirium
timeFrame: 5 month
Secondary outcomes:
measure: the number of days of ventilator use
timeFrame: 5 month
measure: the length of stay at the SICU
timeFrame: 5 month
measure: the length of stay at hospital
timeFrame: 5 month
measure: the rate of re-admission to the SICU
timeFrame: 5 month
measure: mortality rate.
timeFrame: 5 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hakjae Lee
Study officials:
References:
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.
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.
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.
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.