Critical CareNCT00998387
Validation of the Korean Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
An observational study of Critical Care, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to medical ICU at Seoul National University Hospital longer than 24 hours
Who may be able to join
- older than 18 years
- admitted to medical ICU at Seoul National University Hospital longer than 24 hours
Who cannot join
- comatose or moribund state throughout the study period
- preexisting neurologic problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation and Validation of the Korean Version of Confusion Assessment Method for the Intensive Care Unit
The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU setting.
- Conditions
- Critical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| medical ICU | admitted to medical ICU at Seoul National University Hospital longer than 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater reliability of Korean CAM-ICU
Measured: after completion of study
Sensitivity of Korean CAM-ICU for diagnosing ICU delirium
Measured: after completion of study
Specificity of Korean CAM-ICU for diagnosing ICU delirium
Measured: after completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sang Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998387
- Sponsor's protocol ID
- 0803-058-239
- Status last verified
- Oct 2009
- First submitted
- 16 Oct 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Korean Version of Confusion Assessment Method for the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00998387
- Acronym / sponsor ID
- 0803-058-239
- Conditions
- Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to translate and validate the CAM-ICU for use in the Korean ICU setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical ICU | – | –admitted to medical ICU at Seoul National University Hospital longer than 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to medical ICU at Seoul National University Hospital longer than 24 hours
Key inclusion criteria (2 listed)
- older than 18 years
- admitted to medical ICU at Seoul National University Hospital longer than 24 hours
Key exclusion criteria (2 listed)
- comatose or moribund state throughout the study period
- preexisting neurologic problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interrater reliability of Korean CAM-ICU
Time frame: after completion of study
Sensitivity of Korean CAM-ICU for diagnosing ICU delirium
Time frame: after completion of study
Specificity of Korean CAM-ICU for diagnosing ICU delirium
Time frame: after completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater reliability of Korean CAM-ICU (time frame: after completion of study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.