NCT04042649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2014

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

July 31, 2019

Last Update Submit

August 1, 2019

Conditions

Delirium

Keywords

intensive care unitcritically ill patientsenvironmental intervention

Outcome Measures

Primary Outcomes (3)

  • the incidence rate of delirium

    5 month

  • time to delirium onset

    5 month

  • the duration of delirium

    5 month

Secondary Outcomes (5)

  • the number of days of ventilator use

    5 month

  • the length of stay at the SICU

    5 month

  • the length of stay at hospital

    5 month

  • the rate of re-admission to the SICU

    5 month

  • mortality rate.

    5 month

Study Arms (2)

pre-intervention

NO INTERVENTION

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

post-intervention

EXPERIMENTAL

After providing environmental intervention for critically ill patients

Behavioral: environmental intervention

Interventions

environmental interventionBEHAVIORAL

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

post-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hakjae Lee

Seoul, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 8092177RESULT

  • 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.

    PMID: 23978407RESULT

  • 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.

    PMID: 15082703RESULT

  • 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.

    PMID: 23317943RESULT

MeSH Terms

Conditions

Delirium

Interventions

Milieu Therapy

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

June 1, 2013

Primary Completion

October 31, 2014

Study Completion

October 31, 2014

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)