Postoperative DeliriumPOD-INCT02131181
Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients
An observational study of Postoperative Delirium, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- How many people
- 400 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2013to Feb 2015
- How long will I take part?
- 6 Months
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing scheduled non-cardiac operation
Who may be able to join
- Age >/ 60 years
- American Society of Anesthesiologists (ASA) physical status 1-3
- Undergoing scheduled surgery
- Giving an informed consent
Who cannot join
- Impaired visual and auditory disturbance
- Cannot communicate with Thai language
- Undergoing neurosurgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
Maung, Chiang Mai, 50200
About this study
Official title: Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients (POD-I)
The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.
Read the detailed description
The investigators have process of quality assurance for the study including data dictionary, data verification of case record form and site monitoring and auditing.
- Conditions
- Postoperative Delirium
- Keywords
- Delirium, postoperative delirium, elderly
- Medical subject headings
- Emergence Delirium, Delirium
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 |
|---|---|---|
| Delirium | Patients with delirium and patients without delirium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
participants will be followed for the duration of hospital stay, an expected average of 1 week.
Measured: participants will be followed for the duration of hospital stay, an expected average of 1 week.
Secondary outcomes (2)
Factor related to postoperative delirium
Anesthetic technique, Pain score, type of operation
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Long-term outcomes (cognitive impairment)
This outcome will measure only patients who develop delirium after operation.
Measured: 3 and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- 400 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanyong Pipanmekaporn, Chiang Mai University
- Investigators
- Tanyong Pipanmekaporn, MD, Principal investigator, Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131181
- Sponsor's protocol ID
- ANE-131366-FB
- Acronym
- POD-I
- Status last verified
- Feb 2015
- First submitted
- 23 Nov 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Banjongrewadee M, Wongpakaran N, Wongpakaran T, Pipanmekaporn T, Punjasawadwong Y, Mueankwan S. The role of perceived stress and cognitive function on the relationship between neuroticism and depression among the elderly: a structural equation model approach. BMC Psychiatry. 2020 Jan 20;20(1):25. doi: 10.1186/s12888-020-2440-9.
PubMed 31959135
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients (POD-I)
- ClinicalTrials.gov ID
- NCT02131181
- Acronym / sponsor ID
- POD-I / ANE-131366-FB
- Conditions
- Postoperative Delirium
- Keywords
- Delirium, postoperative delirium, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 May 2014 (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 incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.
Detailed description
The investigators have process of quality assurance for the study including data dictionary, data verification of case record form and site monitoring and auditing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delirium | – | –Patients with delirium and patients without delirium |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing scheduled non-cardiac operation
Key inclusion criteria (4 listed)
- Age >/ 60 years
- American Society of Anesthesiologists (ASA) physical status 1-3
- Undergoing scheduled surgery
- Giving an informed consent
Key exclusion criteria (3 listed)
- Impaired visual and auditory disturbance
- Cannot communicate with Thai language
- Undergoing neurosurgery
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
Incidence of postoperative delirium
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week.
participants will be followed for the duration of hospital stay, an expected average of 1 week.
2 secondary outcomes
Factor related to postoperative delirium
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Long-term outcomes (cognitive impairment)
Time frame: 3 and 6 months after operation
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 4 Feb 2015.
- Derived from this study: PubMed 31959135Banjongrewadee M, Wongpakaran N, Wongpakaran T, Pipanmekaporn T, Punjasawadwong Y, Mueankwan S. The role of perceived stress and cognitive function on the relationship between neuroticism and depression among the elderly: a structural equation model approach. BMC Psychiatry. 2020 Jan 20;20(1):25. doi: 10.1186/s12888-020-2440-9.
- Faculty of Medicine, Chiang Mai, ThailandLink provided by the sponsor.
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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, MD principal investigator
Department of Anesthesiology, Faculty ofMedicine, Chiang Mai, University, Chiang Mai, Thailand
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 Postoperative Delirium, run by Chiang Mai University at 1 site 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 4 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: finished, as of the sponsor's last update on 4 Feb 2015. 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 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?
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?
Incidence of postoperative delirium (time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02131181, which also lists 1 linked publication.
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 4 Feb 2015.