Postoperative DeliriumNCT04154176
Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity
An observational study of Postoperative Delirium, run by University of Thessaly at 1 site in Greece.
Trial summary
This study attempts to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- CAM, Nu-DESC
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 15 Dec 2019
- 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 surgery under general anesthesia
Who may be able to join
- adult patients over 60 years of age
- an American Society of Anesthesiologists (ASA) physical status I to III
- undergoing elective non-cardiac surgery under general anaesthesia
- native speakers of the Greek language
- eligible to leave the post-anaesthesia care unit
- an expected in-hospital stay of at least 24 hours following surgery
Who cannot join
- refused to participate or sign the informed consent form
- surgery or anaesthesia within the last 30 day
- any prior or current history involving an affliction of the central nervous system
- severe hearing or visual impairment
- psychiatric disorders
- sa core less than 5 according the Geriatric Depression Scale (GDS-15)
Show all 12Show fewer
- a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
- alcohol consumption less than 35 units/week
- drug dependence
- previous neuropsychological testing
- haemodynamical instability
- peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity: A Prospective Cohort Study
This study attempts to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia.
Read the detailed description
Accurate diagnosis for Greek speaking patients suffering from postoperative delirium is limited by the need for a translation of standardized tools that were investigated for their inter-rater reliability/agreement.
Our primary aim is to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia. Our secondary aim is to estimate the diagnostic accuracy of NuDESK in our population.
This study will provide the first official Greek translation of CAM and Nu-DESC, according to the ISPOR guidelines, and the first evaluation of their inter-rater agreement.
- Conditions
- Postoperative Delirium
- Being tested
- CAM, Nu-DESC
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM, Nu-DESCOther
Two trained raters, who are blinded and have no access to each other's evaluation, administer the CAM and Nu-DESC questionnaires in each shift, during the first postoperative day after the discharge from the post-anaesthesia care unit, independently. The two assessments are completed within 60 minutes of each other. If the research team set the diagnosis of POD, the appropriate treatment will be initiated, according to the Hospital's protocol
| Study group | Role | What they receive |
|---|---|---|
| POD CAM Nu-DESC | Patients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC Receives: Other: CAM, Nu-DESC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC
validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC
Measured: 1st postoperative day
Secondary outcomes (2)
Estimation of the inter-rater agreement of the Greek versions of the CAM and Nu-DESC
estimate the inter-rater agreement of the Greek versions of the CAM and Nu-DESC
Measured: 1st postoperative day
Incidence of POD in our study sample.
Estimate the incidence of POD in our study sample.
Measured: 1st postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Sep 2019
- Primary completion30 Nov 2019
- Study completion15 Dec 2019
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.
- More trials run by University of ThessalyThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Elena Arnaoutoglou, MD, PhD, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154176
- Sponsor's protocol ID
- CAM Nu-DESC in Greek
- Status last verified
- Feb 2021
- First submitted
- 4 Nov 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ntalouka MP, Bareka M, Brotis AG, Chalkias A, Stamoulis K, Flossos A, Tzimas P, Arnaoutoglou E. Translation and cultural adaptation of the Greek version of the confusion assessment method diagnostic algorithm and the nursing delirium screening scale and their inter-rater reliability: A prospective cohort study. Hippokratia. 2020 Jan-Mar;24(1):8-14.
PubMed 33364733
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Greek Version of the Confusion Assessment Method Diagnostic Algorithm (CAM) and the Nursing Delirium Screening Scale (Nu-DESC) and Their Inter-rater Reliablity: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04154176
- Acronym / sponsor ID
- CAM Nu-DESC in Greek
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 6 Nov 2019 (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.
This study attempts to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia.
Detailed description
Accurate diagnosis for Greek speaking patients suffering from postoperative delirium is limited by the need for a translation of standardized tools that were investigated for their inter-rater reliability/agreement.
Our primary aim is to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia. Our secondary aim is to estimate the diagnostic accuracy of NuDESK in our population.
This study will provide the first official Greek translation of CAM and Nu-DESC, according to the ISPOR guidelines, and the first evaluation of their inter-rater agreement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POD CAM Nu-DESC | – | Other: CAM, Nu-DESCPatients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery under general anesthesia
Key inclusion criteria (6 listed)
- adult patients over 60 years of age
- an American Society of Anesthesiologists (ASA) physical status I to III
- undergoing elective non-cardiac surgery under general anaesthesia
- native speakers of the Greek language
- eligible to leave the post-anaesthesia care unit
Key exclusion criteria (12 listed)
- refused to participate or sign the informed consent form
- surgery or anaesthesia within the last 30 day
- any prior or current history involving an affliction of the central nervous system
- severe hearing or visual impairment
- psychiatric disorders
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 |
|---|---|---|
| CAM, Nu-DESCTwo trained raters, who are blinded and have no access to each other's evaluation, administer the CAM and Nu-DESC questionnaires in each shift, during the first postoperative day after the discharge from the post-anaesthesia care unit, independently. The two assessments are completed within 60 minutes of each other. If the research team set the diagnosis of POD, the appropriate treatment will be initiated, according to the Hospital's protocol | Other | POD CAM Nu-DESC |
Primary outcome
Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC
Time frame: 1st postoperative day
validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC
2 secondary outcomes
Estimation of the inter-rater agreement of the Greek versions of the CAM and Nu-DESC
Time frame: 1st postoperative day
Incidence of POD in our study sample.
Time frame: 1st postoperative day
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 5 Feb 2021.
- Results publication: PubMed 33364733Ntalouka MP, Bareka M, Brotis AG, Chalkias A, Stamoulis K, Flossos A, Tzimas P, Arnaoutoglou E. Translation and cultural adaptation of the Greek version of the confusion assessment method diagnostic algorithm and the nursing delirium screening scale and their inter-rater reliability: A prospective cohort study. Hippokratia. 2020 Jan-Mar;24(1):8-14.
- Individual participant dataSharing planned: Undecided
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The Danish Out-of-Hospital Cardiac Arrest Study
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Lactium Premedication to Prevent Emergence Agitation
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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.
Elena Arnaoutoglou, MD, PhD study chair
University of Thessaly
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 University of Thessaly at 1 site in Greece.
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 6 inclusion and 12 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 5 Feb 2021. 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 Greece. 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?
Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC (time frame: 1st postoperative day). 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 NCT04154176, 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 5 Feb 2021.