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CompletedNCT04154176Updated Feb 5, 2021

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 in Postoperative Delirium, sponsored by University of Thessaly. Completed at 1 site in Greece. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.

Sponsored by University of Thessaly · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
60 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Postoperative Delirium
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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 60 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing surgery under general anesthesia

Inclusion criteria

  1. adult patients over 60 years of age
  2. an American Society of Anesthesiologists (ASA) physical status I to III
  3. undergoing elective non-cardiac surgery under general anaesthesia
  4. native speakers of the Greek language
  5. eligible to leave the post-anaesthesia care unit
  6. an expected in-hospital stay of at least 24 hours following surgery

Exclusion criteria

Exclusion Criteria:

  1. refused to participate or sign the informed consent form
  2. surgery or anaesthesia within the last 30 day
  3. any prior or current history involving an affliction of the central nervous system
  4. severe hearing or visual impairment
  5. psychiatric disorders
  6. sa core less than 5 according the Geriatric Depression Scale (GDS-15)
  7. 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.)
  8. alcohol consumption less than 35 units/week
  9. drug dependence
  10. previous neuropsychological testing
  11. haemodynamical instability
  12. peri-procedural desaturation (one or more events of SpO2\<80% for more than 2 minutes)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • POD CAM Nu-DESC

    Patients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC

    Other: CAM, Nu-DESC

Interventions

  • OtherCAM, Nu-DESC

    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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1st postoperative day

Secondary outcomes

  1. 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

    Time frame: 1st postoperative day

  2. Incidence of POD in our study sample.

    Estimate the incidence of POD in our study sample.

    Time frame: 1st postoperative day

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Study locations

1 site
  • Univeristy of Thessaly
    Larissa, Thessaly 41110, Greece
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04154176
Lead sponsor
University of Thessaly
Responsible party
Elena Arnaoutoglou (Professor of Anesthesiology, University of Thessaly) — Principal investigator
First posted
Nov 6, 2019
Start date
Sep 1, 2019
Primary completion
Nov 30, 2019
Completion
Dec 15, 2019
Last update
Feb 5, 2021

Study contacts

Elena Arnaoutoglou, MD, PhD
study chair · University of Thessaly

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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