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

Completed

• Conditions: Postoperative Delirium
• Interventions: Other: CAM, Nu-DESC

• Registration Number: NCT04154176
• Lead Sponsor: University of Thessaly

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POD CAM Nu-DESC	CAM, Nu-DESC	Patients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC

Primary Outcome Measures

Name	Time	Method
Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC	1st postoperative day	validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC

Secondary Outcome Measures

Name	Time	Method
Estimation of the inter-rater agreement of the Greek versions of the CAM and Nu-DESC	1st postoperative day	estimate the inter-rater agreement of the Greek versions of the CAM and Nu-DESC
Incidence of POD in our study sample.	1st postoperative day	Estimate the incidence of POD in our study sample.

Trial Locations

Locations (1)

Univeristy of Thessaly; 🇬🇷 Larissa, Thessaly, Greece