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

NCT ID: NCT04154176

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2019-12-15

Brief Summary

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.

Conditions

Postoperative Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

POD CAM Nu-DESC

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

CAM, Nu-DESC

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Elena Arnaoutoglou

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Arnaoutoglou, MD, PhD

Role: STUDY_CHAIR

University of Thessaly

Locations

Univeristy of Thessaly

Larissa, Thessaly, Greece

Countries

Greece

References

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.

Reference Type: RESULT

PMID: 33364733 (View on PubMed)

Other Identifiers

CAM Nu-DESC in Greek

Identifier Type: -

Identifier Source: org_study_id