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

Postoperative Delirium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04154176
• Other study ID #: CAM Nu-DESC in Greek
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2021
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Confusion
• Delirium
• Postoperative Delirium

Intervention

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

Locations

Country	Name	City	State
Greece	Univeristy of Thessaly	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of POD in our study sample.	Estimate the incidence of POD in our study sample.	1st postoperative day