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NCT Number: NCT04154176

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

This study attempts to validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC in patients undergoing surgery under general anesthesia.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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

Primary outcomes

  1. Validation of the Greek version of the CAM Diagnostic Algorithm and Nu-DESC

    Time frame: 1st postoperative day

    validate the Greek version of the CAM Diagnostic Algorithm and Nu-DESC

Secondary outcomes

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

    Time frame: 1st postoperative day

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

  2. Incidence of POD in our study sample.

    Time frame: 1st postoperative day

    Estimate the incidence of POD in our study sample.

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2019
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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