Postoperative DeliriumNCT05992818
Comparison of DRS-R-98 and 3D-CAM in the Assessment of Postoperative Delirium in Elderly Patients
An observational study of Postoperative Delirium, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative delirium (POD) is a transient and usually fully reversible altered state of consciousness that develops acutely or subacutely after surgery, characterized by widespread, daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania), hypoactive (depressive) and mixed type. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- comparing DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium) tests to assess postoperative delirium
- How many people
- 270 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2023to 25 Dec 2023
- How long will I take part?
- 2 Days
- 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
- Healthy volunteers accepted
- Older adult
Study population: ≥ 65 years male and female orthopedic, urological, thoracic, vascular (off-pump) and general surgery operations
Who may be able to join
- orthopedic, urological, thoracic, vascular and general surgery operations
- Emergency and elective surgery
- Patients with voluntary consent
- Patients aged ≥ 65 years
- Surgeries longer than 60 minutes
Who cannot join
- < 65 years old patients
- Operations that take less than 60 minutes
- Patients who do not speak Turkish
- Patients who cannot legally give consent (eg dementia)
- Patients without consent
- Outpatient surgeries
- Reoperated or reintubated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute Diagnostic Assessment for CAM-Confusion Assessment Method-defined Delirium) in the Assessment of Postoperative Delirium in Elderly Patients
Postoperative delirium (POD) is a transient and usually fully reversible altered state of consciousness that develops acutely or subacutely after surgery, characterized by widespread, daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania), hypoactive (depressive) and mixed type. It has been shown to be associated with increased morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46% in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic, opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk factors associated with delirium. This condition, which has a multifactorial etiology, is often unrecognized, unpreventable, untreatable and leads to increased morbidity and mortality. Therefore, it is important to recognize delirium that develops in the postoperative period and to perform the necessary interventions.
There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient under many sub-headings such as orientation, memory, attention, visual and spatial ability.
Read more
The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these tests are useful for the clinician in the diagnosis of delirium.
The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their feasibility and the power detecting delirium.
Read the detailed description
Postoperative delirium (POD) is a transient and usually fully reversible altered state of consciousness that develops acutely or subacutely after surgery, characterized by widespread, daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania), hypoactive (depressive) and mixed type. It has been shown to be associated with increased morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46% in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic, opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk factors associated with delirium. This condition, which has a multifactorial etiology, is often unrecognized, unpreventable, untreatable and leads to increased morbidity and mortality. Therefore, it is important to recognize delirium that develops in the postoperative period and to perform the necessary interventions.
There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient under many sub-headings such as orientation, memory, attention, visual and spatial ability. The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these tests are useful for the clinician in the diagnosis of delirium. The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their feasibility and the power detecting delirium.
After obtaining ethics committee approval, all patients who undergo orthopedic, urological, general surgery, thoracic and vascular surgery operations in the Istanbul Faculty of Medicine, above 65 years old, with an operation duration longer than 60 minutes will include in this study. Patients who are re-operated, require re-intubation or withdraw their consent will be excluded from the study. This study is planned as an observational, prospective study. Demographic information such as age, gender, height, weight, comorbidities, duration of operation and anesthesia, postoperative pain level, anesthesia and analgesia management, intensive care and hospitalization periods will be recorded from their files. On postoperative day 1, delirium development will be evaluated with DSM-5 diagnostic criteria. All patients will also be evaluated by another physician with both DRS-R-98 and 3D-CAM tests. The same tests will be repeated on postoperative day 2.
- Conditions
- Postoperative Delirium
- Being tested
- comparing DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium) tests to assess postoperative delirium
- Keywords
- Elderly patients, DRS-R-98(The Delirium Rating Scale--Revised-98), 3D-CAM, delirium
- 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.
comparing DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium) tests to assess postoperative deliriumDiagnostic test
determine the test that is more effective and practical in the assessment of POD
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium.
the specificity, sensitivity and consistency of 3D-CAM and DRS-R-98 tests used in the evaluation of postoperative delirium. Both tests include sections that assess the patient's responses to the questions asked and also the practitioner's observations
Measured: 2 days
Secondary outcomes (3)
incidence of postoperative delirium
determine the incidence of postoperative delirium
Measured: 2 days
length of hospital stay
examine the relationship between delirium and hospital stay
Measured: 2-21 days
postoperative pain assessment with Numeric Rating Scale (NRS)
Numerical rating scales (NRSs) are the simplest and most commonly used scales.The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start16 Aug 2023
- Primary completion20 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- 270 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Turhan, Istanbul University
- Investigators
- Zerrin SUNGUR, Prof Dr, Study chair, Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992818
- Sponsor's protocol ID
- 2022/2132
- Status last verified
- Mar 2024
- First submitted
- 5 Aug 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh ST, Park JY. Postoperative delirium. Korean J Anesthesiol. 2019 Feb;72(1):4-12. doi: 10.4097/kja.d.18.00073.1. Epub 2018 Aug 24.
PubMed 30139213Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.
PubMed 31354253American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5Ⓡ). 5th ed. Arlington, American Psychiatric Association Publishing. 2013, pp 596-601.
Palihnich K, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. 2014; Boston: Hospital Elder Life Program
Cinar MA,Ozmenler KN ,Ozsahin A ,Trzepacz Paula T. Dusunen Adam The Journal of Psychiatry and Neurological Sciences 2014; 3(27): 186-193 DOI: 10.5350/DAJPN2014270301
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute Diagnostic Assessment for CAM-Confusion Assessment Method-defined Delirium) in the Assessment of Postoperative Delirium in Elderly Patients
- ClinicalTrials.gov ID
- NCT05992818
- Acronym / sponsor ID
- 2022/2132
- Conditions
- Postoperative Delirium
- Keywords
- Elderly patients, DRS-R-98(The Delirium Rating Scale--Revised-98), 3D-CAM, delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 15 Aug 2023 (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.
Postoperative delirium (POD) is a transient and usually fully reversible altered state of consciousness that develops acutely or subacutely after surgery, characterized by widespread, daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania), hypoactive (depressive) and mixed type. It has been shown to be associated with increased morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46% in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic, opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk factors associated with delirium. This condition, which has a multifactorial etiology, is often unrecognized, unpreventable, untreatable and leads to increased morbidity and mortality. Therefore, it is important to recognize delirium that develops in the postoperative period and to perform the necessary interventions.
There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient under many sub-headings such as orientation, memory, attention, visual and spatial ability.
The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these tests are useful for the clinician in the diagnosis of delirium.
The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their feasibility and the power detecting delirium.
Detailed description
Postoperative delirium (POD) is a transient and usually fully reversible altered state of consciousness that develops acutely or subacutely after surgery, characterized by widespread, daily fluctuations in brain metabolism and function. It can be seen as hyperactive (mania), hypoactive (depressive) and mixed type. It has been shown to be associated with increased morbidity, mortality, health expenditures and prolonged hospitalization in the postoperative period. In studies, the frequency of POD was found to be 17-51% in orthopedic surgery, 11-46% in cardiac surgery and 13-50% in non-cardiac surgery. There are many studies in the literature on advanced age, comorbidities (e. g; diabetes mellitus, stroke, coronary artery disease, arrhythmias), dementia, use of glasses-hearing aids, medications (anticholinergic, opioid, benzodiazepine etc. ), duration of anesthesia, type of surgery, electrolyte disturbances, perioperative bleeding, hypotension, pain and intensive care unite stay as risk factors associated with delirium. This condition, which has a multifactorial etiology, is often unrecognized, unpreventable, untreatable and leads to increased morbidity and mortality. Therefore, it is important to recognize delirium that develops in the postoperative period and to perform the necessary interventions.
There are many tests used in the diagnosis of POD. Delirium tests; it evaluates the patient under many sub-headings such as orientation, memory, attention, visual and spatial ability. The gold standard method is DSM-V (North American Diagnostic and Statistical Manual-V of Mental Disorders-V) to assess delirium status. There are also some other tests like DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium). In addition to patient assessment, these tests are useful for the clinician in the diagnosis of delirium. The aim of the study is to compare the DRS-R-98 and 3D-CAM tests used in the assessment of POD, and to evaluate their feasibility and the power detecting delirium.
After obtaining ethics committee approval, all patients who undergo orthopedic, urological, general surgery, thoracic and vascular surgery operations in the Istanbul Faculty of Medicine, above 65 years old, with an operation duration longer than 60 minutes will include in this study. Patients who are re-operated, require re-intubation or withdraw their consent will be excluded from the study. This study is planned as an observational, prospective study. Demographic information such as age, gender, height, weight, comorbidities, duration of operation and anesthesia, postoperative pain level, anesthesia and analgesia management, intensive care and hospitalization periods will be recorded from their files. On postoperative day 1, delirium development will be evaluated with DSM-5 diagnostic criteria. All patients will also be evaluated by another physician with both DRS-R-98 and 3D-CAM tests. The same tests will be repeated on postoperative day 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- ≥ 65 years male and female orthopedic, urological, thoracic, vascular (off-pump) and general surgery operations
Key inclusion criteria (5 listed)
- orthopedic, urological, thoracic, vascular and general surgery operations
- Emergency and elective surgery
- Patients with voluntary consent
- Patients aged ≥ 65 years
- Surgeries longer than 60 minutes
Key exclusion criteria (7 listed)
- < 65 years old patients
- Operations that take less than 60 minutes
- Patients who do not speak Turkish
- Patients who cannot legally give consent (eg dementia)
- Patients without consent
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 |
|---|---|---|
| comparing DRS-R-98 (The Delirium Rating Scale--Revised-98) and 3D-CAM (3-minute diagnostic assessment for CAM-Confusion Assessment Method-defined delirium) tests to assess postoperative deliriumdetermine the test that is more effective and practical in the assessment of POD | Diagnostic test | – |
Primary outcome
Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium.
Time frame: 2 days
the specificity, sensitivity and consistency of 3D-CAM and DRS-R-98 tests used in the evaluation of postoperative delirium. Both tests include sections that assess the patient's responses to the questions asked and also the practitioner's observations
3 secondary outcomes
incidence of postoperative delirium
Time frame: 2 days
length of hospital stay
Time frame: 2-21 days
postoperative pain assessment with Numeric Rating Scale (NRS)
Time frame: 2 days
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 12 Mar 2024.
- Results publication: PubMed 30139213Oh ST, Park JY. Postoperative delirium. Korean J Anesthesiol. 2019 Feb;72(1):4-12. doi: 10.4097/kja.d.18.00073.1. Epub 2018 Aug 24.
- Results publication: PubMed 31354253Janssen TL, Alberts AR, Hooft L, Mattace-Raso F, Mosk CA, van der Laan L. Prevention of postoperative delirium in elderly patients planned for elective surgery: systematic review and meta-analysis. Clin Interv Aging. 2019 Jun 19;14:1095-1117. doi: 10.2147/CIA.S201323. eCollection 2019.
- Results publicationAmerican Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-5Ⓡ). 5th ed. Arlington, American Psychiatric Association Publishing. 2013, pp 596-601.
- Results publicationPalihnich K, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. 2014; Boston: Hospital Elder Life Program
- Results publicationCinar MA,Ozmenler KN ,Ozsahin A ,Trzepacz Paula T. Dusunen Adam The Journal of Psychiatry and Neurological Sciences 2014; 3(27): 186-193 DOI: 10.5350/DAJPN2014270301
- Individual participant dataSharing planned: No
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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.
Zerrin SUNGUR, Prof Dr study chair
Istanbul University Istanbul Faculty of Medicine Department of Anesthesiology and Reanimation
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 Istanbul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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 12 Mar 2024. 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 Turkey (Türkiye). 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?
Comparing the tests (3D-CAM and DRS-R-98) in the assessment of postoperative delirium. (time frame: 2 days). 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 NCT05992818, which also lists 5 linked publications.
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 12 Mar 2024.