Validation of the Korean Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
| ISRCTN | ISRCTN50265663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50265663 |
| Protocol serial number | N/A |
| Sponsor | Seoul National University Hospital (South Korea) |
| Funder | Seoul National University Hospital (South Korea) |
- 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
Scientific
Department of Internal Medicine
Seoul National University Hospital
101 Daehangno, Jongno-gu
Seoul
110-744
Korea, South
| Phone | +82 (0)2 2072 0833 |
|---|---|
| sangmin2@snu.ac.kr |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
Measured after collection of all data: |
| Key secondary outcome measure(s) |
The ratio of delirium development, measured after collection of all data |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
110-744
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
