Delirium in Old AgeNCT04656379
The Incidence and Risk Factors of Postoperative Delirium
An observational study of Delirium in Old Age, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery. Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 10 Feb 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged ≥65 and underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital
Who may be able to join
- Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital
Who cannot join
- Patients who had no information on postoperative care and managements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence and Risk Factors of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery. Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance. However, there have been few reports concerning intraoperative modifiable risk factors, such as postoperative pain, for postoperative delirium.
Read the detailed description
In this observational study, we will review the electronic medical records of elderly patients underwent spine surgery and assess the incidence and risk factors for postoperative delirium.
- Conditions
- Delirium in Old Age
- Being tested
- spine surgery
- Keywords
- postoperative delirium, elderly, spine surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine surgeryProcedure or surgery
Risk factors for postoperative delirium in elderly patients underwent spine surgery will be evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
Incidence of delirium after spine surgery
Measured: through study completion, postoperative period up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Sep 2019
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
- Investigators
- Youn Joung Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656379
- Sponsor's protocol ID
- delirium_risk factors
- Status last verified
- Feb 2022
- First submitted
- 30 Nov 2020
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Risk Factors of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT04656379
- Acronym / sponsor ID
- delirium_risk factors
- Conditions
- Delirium in Old Age
- Keywords
- postoperative delirium, elderly, spine surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 7 Dec 2020 (actual)
- 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.
Delirium is known to be one of the most common postoperative complications in elderly patients undergoing surgery. Because postoperative delirium can affect the length of hospital stay and prognosis significantly, it is important to identify the risk factors for postoperative delirium in advance. However, there have been few reports concerning intraoperative modifiable risk factors, such as postoperative pain, for postoperative delirium.
Detailed description
In this observational study, we will review the electronic medical records of elderly patients underwent spine surgery and assess the incidence and risk factors for postoperative delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥65 and underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital
Key inclusion criteria (1 listed)
- Patients who underwent spine surgery between September 2016 and August 2018 at Seoul National University Hospital
Key exclusion criteria (1 listed)
- Patients who had no information on postoperative care and managements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spine surgeryRisk factors for postoperative delirium in elderly patients underwent spine surgery will be evaluated. | Procedure or surgery | – |
Primary outcome
Incidence of delirium
Time frame: through study completion, postoperative period up to 2 years after surgery
Incidence of delirium after spine surgery
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 11 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Youn Joung Cho, 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 Delirium in Old Age, 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 1 inclusion and 1 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 11 Feb 2022. 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?
Incidence of delirium (time frame: through study completion, postoperative period up to 2 years after surgery). 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 11 Feb 2022.