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Risk factor for occurs of delirium in stepdown unit surgical patients

Status Approved

First Submitted Date

2021/01/13
Registered Date

2021/01/22
Last Updated Date

2021/01/13

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005813
Unique Protocol ID	S2020-2691-0002
Public/Brief Title	Risk factor for occurs of delirium in stepdown unit surgical patients
Scientific Title	Risk factor for occurs of delirium in stepdown unit surgical patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-1830
Approval Date	2020-12-11
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	Yes Asan Medical Center Institutional

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Soyeon Yoon
Title	Registered nurse
Telephone	+82-2-3010-6431
Affiliation	Asan Medical Center
Address	88 ,Olympic-ro 43-gil Songpa-gu Seoul, Republic of Korea
Contact Person for Public Queries
Name	Jinjoo Kim
Title	Registered nurse
Telephone	+82-2-3010-6431
Affiliation	Asan Medical Center
Address	88 ,Olympic-ro 43-gil Songpa-gu Seoul, Republic of Korea
Contact Person for Updating Information
Name	Soyeon Yoon
Title	Registered nurse
Telephone	+82-2-3010-6431
Affiliation	Asan Medical Center
Address	88 ,Olympic-ro 43-gil Songpa-gu Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-12-11 Actual
Target Number of Participant	227
Primary Completion Date	2021-01-31 , Anticipated
Study Completion Date	2021-02-28 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2020-12-11 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Asan Medical Center
Organization Type	Medical Institute
Project ID	2020-1830

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Introduction Recently, Aging age and various treatments have been introduced according to the development of medical technology, the demand for patients who have received long-term intensive care has increased. The need for ICU beds increased and early transfer to general ward increased ICU readmitted and mortality. In consideration of the problems between the intensive care unit and the general ward, a department that provides intermediate nursing was established in an effort to prevent long-term hospitalization in the intensive care unit and to maintain the continuity of intensive care. In Korea, a semi-intensive care unit has been newly established since 2017 mainly in advanced hospitals and long term intensive care patients nursing and intensive monitoring after surgery and procedures for high-risk patients with chronic basal diseases. In 47% of the patients with delirium in the intensive care unit, delirium persists after transferring ICU, and in 75% of the patients who were confused or coma with consciousness, delirium newly develops after transferring ICU. When delirium is not treated, long-term cognitive dysfunction, falls, and hospitalization stay increase. Delirium needs to be managed, and the most widely used tools in the world as a delirium assessment tool are Confused Assessment Method (CAM). This requires more than 10 minutes to evaluate delirium, so it is difficult to use in the ward, so it is necessary to evaluate delirium in a short period of time. Short CAM-Score is a short form based on CAM algorithm and is designed in 2014 (Michele G, Sullivan, 2014), completed within 5 minutes, can be evaluated in a short period of time, providing simple evaluation and severity score of delirium. As delirium scoring increased, hospital hospital stay days increased, cognitive function decreased. Especially, Short CAM-Score was highly utilized especially for elderly patients over 70 years old Purpose In this study, we retrospectively investigated factors that have a comprehensive impact on delirium development, including patient-related characteristics, disease-related characteristics, treatment-related characteristics, and environmental-related characteristics, targeting surgical step down patients using Short CAM-Score. Based on this, the study aims to provide basic data for intervention in the event of surgical step down unit patient delirium.

Study Summary Information

Lay Summary

Introduction
Recently, Aging age and various treatments have been introduced according to the development of medical technology, the demand for patients who have received long-term intensive care has increased. 
The need for ICU beds increased and early transfer to general ward increased ICU readmitted and mortality.
In consideration of the problems between the intensive care unit and the general ward, a department that provides intermediate nursing was established in an effort to prevent long-term hospitalization in the intensive care unit and to maintain the continuity of intensive care.
In Korea, a semi-intensive care unit has been newly established since 2017 mainly in advanced hospitals and  long term intensive care patients nursing and intensive monitoring after surgery and procedures for high-risk patients with chronic basal diseases.
In 47&#37; of the patients with delirium in the intensive care unit, delirium persists after transferring ICU, and in 75&#37; of the patients who were confused or coma with consciousness, delirium newly develops after transferring ICU. When delirium is not treated, long-term cognitive dysfunction, falls, and hospitalization stay increase.
Delirium needs to be managed, and the most widely used tools in the world as a delirium assessment tool are Confused Assessment Method (CAM). This requires more than 10 minutes to evaluate delirium, so it is difficult to use in the ward, so it is necessary to evaluate delirium in a short period of time.
Short CAM-Score is a short form based on CAM algorithm and is designed in 2014 (Michele G, Sullivan, 2014), completed within 5 minutes, can be evaluated in a short period of time, providing simple evaluation and severity score of delirium. As delirium scoring increased, hospital hospital stay days increased, cognitive function decreased. Especially, Short CAM-Score was highly utilized especially for elderly patients over 70 years old
Purpose
In this study, we retrospectively investigated factors that have a comprehensive impact on delirium development, including patient-related characteristics, disease-related characteristics, treatment-related characteristics, and environmental-related characteristics, targeting surgical step down patients using Short CAM-Score.
Based on this, the study aims to provide basic data for intervention in the event of surgical step down unit patient delirium.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	227
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Delirium group
Cohort/ Group 1	Cohort/Group Description Delirium groups are defined as patients with short-CAM Score of 2 or more points.
Cohort/ Group 2	Cohort/Group Label Non delirium group
Cohort/ Group 2	Cohort/Group Description Delirium groups are defined as patients with less than two short-CAM scores.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients who admitted the stepdown unit of Asan Medical Center in Seoul from February 1 to July 31, 2020
Sampling Method	The results of G*Power program 3.1.9.2 for Windows were used to verify the appropriateness of the sample. The significance level (.05), the intermediate effect size .5, and the power (1-β) were used for independent t-test. The number of samples was 210 based on 95, and 227 of the study were sufficient.
Condition(s)/Problem(s)	* (F00-F99)Mental and behavioural disorders (F05.8)Other delirium Delirium is a disorder characterized by confusion,inattentiveness, disorientation; illusion, halluciation, agitation and in some instances autonomic nervous system overactivity. It may result from toxic/metabolic conditions or structural brain lesions.
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~90Year
	Description Indication 1. Adults over 18 years old 2. Those who have admitted the surgical step down unit stayed for more than 24 hours 3. Short CAM-S score evaluated daily during hospitalization is 2 or higher 4. Patients who can communicate necessary for delirium assessment
Exclusion Criteria	Exclusion 1. Patients who have left the surgical step down unit before 24 hours 2. Patients with dementia before hospitalization 3. Patients unable to communicate verbally as tracheostomy patients
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Risk Factors of Delirium in Patients in Surgical Step down Unit
Timepoint	December 11, 2020 to January 31, 2021
Secondary Outcome(s) 1
Outcome	Characteristics and Pattern in Patients with Delirium
Timepoint	December 11, 2020 to January 31, 2021
Secondary Outcome(s) 2
Outcome	Comparison of general characteristics of delirium group and non-delirum group
Timepoint	December 11, 2020 to January 31, 2021
Secondary Outcome(s) 3
Outcome	Comparison of clinical outcomes between delirium group and non-delirium group
Timepoint	December 11, 2020 to January 31, 2021

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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