Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154176
Recruitment Status : Active, not recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, 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.

Condition or disease Intervention/treatment
Postoperative Delirium Other: CAM, Nu-DESC

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
POD CAM Nu-DESC
Patients undergoing surgery under general anesthesia assessed for POD with CAM and Nu-DESC
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing surgery under general anesthesia
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154176


Locations
Layout table for location information
Greece
Univeristy of Thessaly
Larissa, Thessaly, Greece, 41110
Sponsors and Collaborators
University of Thessaly
Investigators
Layout table for investigator information
Study Chair: Elena Arnaoutoglou, MD, PhD University of Thessaly
Layout table for additonal information
Responsible Party: Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT04154176    
Other Study ID Numbers: CAM Nu-DESC in Greek
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders