DeliriumNCT01267630
The Validity of the Thai Version of the Confusion Assessment Method
An observational study of Delirium, run by Chiang Mai University at 3 sites in Thailand.
Trial summary
The purpose of this study is to determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Delirium
- How many people
- 70 participants
- Where
- 3 sitesThailand
- Study dates
- Jan 2011to Nov 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours.
Who may be able to join
- age ≥ 55 years old
Who cannot join
- Severe visual or auditory impairment
- Comatose or moribund patients
- Unable to communicate with Thai language
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Chiang Mai University Hospital
Maung, Chiang Mai, 50200
Department of Anesthesiology, Faculty of Medicine
Maung, Chiang Mai, 50200
Chiang Mai University Hospital
Muang, Chiang Mai, 50200
About this study
Official title: The Validity and Reliability of Thai Version of the Confusion Assessment Method for the Intensive Care Unit (CAM -ICU)
The purpose of this study is to determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly.
Read the detailed description
The incidence of delirium in intensive care unit varied between 20 and 80% depending on many factors such as types of study, diagnostic tools, severity of patients.The occurrence of delirium is common in elderly patients. However, the prevalence of delirium in the intensive care has not been reported in Thailand. There is no common tool used for detecting delirium in Thai ICU. Currently, CAM-ICU has been developed for nonpsychiatric physician and other health care professionals to detect delirium. The sensitivity and specificity of CAM-ICU was 91-93% and 89-100% respectively. In addition, it has been translated to many version to diagnose deliriums for all over the world. In Thailand, there is no common tool used for detecting delirium in ICU. The use of CAM-ICU may be useful in Thai ICU settings.
- Conditions
- Delirium
- Keywords
- Delirium of Mixed Origin, Subacute Delirium, Mental Disorders, Organic, Organic Brain Syndrome, Nonpsychotic, Organic Mental Disorders, Organic Mental Disorders, Psychotic, Psychoses, Traumatic, Cognition Disorder, Confusion state, Disorientation
- Medical subject headings
- Delirium, Neurocognitive Disorders, Cognition Disorders, Confusion
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 |
|---|---|---|
| Surgical ICU | Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Thai version of the CAM-ICU for diagnosis of ICU delirium
Measured: within 48 hours after admission
Secondary outcomes (1)
The prevalence of elderly delirium patients in intensive care unit
Measured: within 48 hours after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Investigators
- Tanyong Pipanmekaporn, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267630
- Sponsor's protocol ID
- ANE100806A11
- Other IDs
- ANE10-08-06A-11
- Status last verified
- Jan 2011
- First submitted
- 27 Dec 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of Thai Version of the Confusion Assessment Method for the Intensive Care Unit (CAM -ICU)
- ClinicalTrials.gov ID
- NCT01267630
- Acronym / sponsor ID
- ANE100806A11
- Conditions
- Delirium
- Keywords
- Delirium of Mixed Origin, Subacute Delirium, Mental Disorders, Organic, Organic Brain Syndrome, Nonpsychotic, Organic Mental Disorders, Organic Mental Disorders, Psychotic, Psychoses, Traumatic, Cognition Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 28 Dec 2010 (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 determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly.
Detailed description
The incidence of delirium in intensive care unit varied between 20 and 80% depending on many factors such as types of study, diagnostic tools, severity of patients.The occurrence of delirium is common in elderly patients. However, the prevalence of delirium in the intensive care has not been reported in Thailand. There is no common tool used for detecting delirium in Thai ICU. Currently, CAM-ICU has been developed for nonpsychiatric physician and other health care professionals to detect delirium. The sensitivity and specificity of CAM-ICU was 91-93% and 89-100% respectively. In addition, it has been translated to many version to diagnose deliriums for all over the world. In Thailand, there is no common tool used for detecting delirium in ICU. The use of CAM-ICU may be useful in Thai ICU settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical ICU | – | –Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours . |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are admitted to the surgical ICU of Chiang Mai University Hospital within 48 hours.
Key inclusion criteria (1 listed)
- age ≥ 55 years old
Key exclusion criteria (3 listed)
- Severe visual or auditory impairment
- Comatose or moribund patients
- Unable to communicate with Thai language
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
Sensitivity and Specificity of Thai version of the CAM-ICU for diagnosis of ICU delirium
Time frame: within 48 hours after admission
1 secondary outcome
The prevalence of elderly delirium patients in intensive care unit
Time frame: within 48 hours after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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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.
Tanyong Pipanmekaporn principal investigator
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Chiang Mai University at 3 sites in Thailand.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. 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?
Results are not available in the source record.
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?
Sensitivity and Specificity of Thai version of the CAM-ICU for diagnosis of ICU delirium (time frame: within 48 hours after admission). 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 23 Jun 2011.