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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Other: CAM, Nu-DESC

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, 41110
      • Univeristy of Thessaly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery under general anesthesia

Description

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:

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: CAM, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1st postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1st postoperative day
Incidence of POD in our study sample.	Estimate the incidence of POD in our study sample.	1st postoperative day

Collaborators and Investigators

• Sponsor: University of Thessaly

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Confusion
• Other Study ID Numbers: CAM Nu-DESC in Greek

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No