Contact information
Type
Scientific
Primary contact
Dr Sang-Min Lee
ORCID ID
Contact details
Department of Internal Medicine
Seoul National University Hospital
101 Daehangno
Jongno-gu
Seoul
110-744
Korea
South
+82 (0)2 2072 0833
sangmin2@snu.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Translation and validation of the Korean version of the Confusion Assessment Method for the Intensive Care Unit: a prospective observational cohort study
Acronym
Study hypothesis
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
Seoul National University Hospital Institutional Review Board approved on the 10th June 2008 (ref: 0803-058-239)
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/07/2008
Overall trial end date
31/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 18 years, either sex
2. Admitted to medical ICU at Seoul National University Hospital for longer than 24 hours
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
63
Participant exclusion criteria
Comatose or moribund state throughout the study period
Recruitment start date
01/07/2008
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Internal Medicine
Seoul
110-744
Korea, South
Sponsor information
Organisation
Seoul National University Hospital (South Korea)
Sponsor details
101 Daehang-no
Jongno-gu
Seoul
110-744
Korea
South
Sponsor type
Hospital/treatment centre
Website
http://medicine0.snu.ac.kr/eng/se11_ho/se11_ho_a/se11_ho_a.jsp
Funders
Funder type
Hospital/treatment centre
Funder name
Seoul National University Hospital (South Korea)
Alternative name(s)
SNUH
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list