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

NCT04154176 | Completed

• 1 other identifier: CAM Nu-DESC in Greek
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Outcome Measures

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

  1st postoperative day

Secondary Outcomes (2)

• Estimation of the inter-rater agreement of the Greek versions of the CAM and Nu-DESC

  1st postoperative day

• Incidence of POD in our study sample.

  1st postoperative day

Study Arms (1)

POD CAM Nu-DESC

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

Other: CAM, Nu-DESC

Interventions

CAM, Nu-DESC 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

POD CAM Nu-DESC

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery under general anesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Univeristy of Thessaly

Larissa, Thessaly, 41110, Greece

Location

Related 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 their inter-rater reliability: A prospective cohort study. Hippokratia. 2020 Jan-Mar;24(1):8-14.

  PMID: 33364733 RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Elena Arnaoutoglou, MD, PhD

  University of Thessaly

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: September 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 15, 2019
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

GR (1)