Condition category
Not Applicable
Date applied
14/10/2009
Date assigned
26/10/2009
Last edited
26/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

government non-federal

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes