Validation of the Korean Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

ISRCTN	ISRCTN50265663
DOI	https://doi.org/10.1186/ISRCTN50265663
Secondary identifying numbers	N/A

Submission date: 14/10/2009
Registration date: 26/10/2009
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sang-Min Lee
Scientific

Department of Internal Medicine
Seoul National University Hospital
101 Daehangno, Jongno-gu
Seoul
110-744
Korea, South

Phone	+82 (0)2 2072 0833
Email	sangmin2@snu.ac.kr

Study information

Study design	Prospective observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Translation and validation of the Korean version of the Confusion Assessment Method for the Intensive Care Unit: a prospective observational cohort study
Study objectives	The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), which originated in the United States of America could be used in a Korean ICU setting.
Ethics approval(s)	Seoul National University Hospital Institutional Review Board approved on the 10th June 2008 (ref: 0803-058-239)
Health condition(s) or problem(s) studied	Critical condition requiring entry to ICU
Intervention	Two nurses independently assessed delirium in ICU patients and the results were compared with the reference evaluation, which was carried out by a psychiatrist using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). Assessment of delirium was performed three times a week and continued until the enrolled patients left the medical ICU. All the assessments were done between three and seven o'clock in the afternoon to avoid any bias from changes in patients' condition.
Intervention type	Other
Primary outcome measure	Measured after collection of all data: 1. Sensitivity 2. Specificity 3. Interrater reliability of the Korean CAM-ICU
Secondary outcome measures	The ratio of delirium development, measured after collection of all data
Overall study start date	01/07/2008
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	63
Total final enrolment	22
Key inclusion criteria	1. Aged over 18 years, either sex 2. Admitted to medical ICU at Seoul National University Hospital for longer than 24 hours
Key exclusion criteria	Comatose or moribund state throughout the study period
Date of first enrolment	01/07/2008
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Korea, South

Study participating centre

Department of Internal Medicine

Seoul
110-744
Korea, South

Sponsor information

Seoul National University Hospital (South Korea)
Hospital/treatment centre

101 Daehang-no
Jongno-gu
Seoul
110-744
Korea, South

Website	http://medicine0.snu.ac.kr/eng/se11_ho/se11_ho_a/se11_ho_a.jsp
"ROR"	https://ror.org/01z4nnt86

Funders

Funder type

Hospital/treatment centre

Seoul National University Hospital (South Korea)
Government organisation / Local government

Alternative name(s): SNUH
Location: Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/05/2011	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.