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Clinical Trials/NCT02760446
NCT02760446
Completed
N/A

Validation of the French Confusion Assessment Method for the Intensive Care Unit Among Adult ICU Patient

University Hospital, Montpellier1 site in 1 country115 target enrollmentNovember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patients With Mental Confusion
Sponsor
University Hospital, Montpellier
Enrollment
115
Locations
1
Primary Endpoint
Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult, \> or equal to 18-yr
  • Richmond Agitation Sedation Scale (RASS) \> or equal -3
  • Francophone

Exclusion Criteria

  • Diagnostic of cognitive disorders
  • Admission for brain injury
  • Psychotic disorders
  • Diagnostic of cognitive disorders
  • Visual or auditory impairments

Outcomes

Primary Outcomes

Statistical criteria of performance (sensibility, specificity, negative predictive value, positive predictive value) of Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) compared to gold standard (neuropsychologist).

Time Frame: Day 0

Investigators team: evaluation by the CAM- ICU in French and Intensive Care Delirium Screening Check list (ICDSC) during 2 minutes for the concomitant CAM- ICU and ICDSC , carried out at 30 minutes intervals by two Clinical Research Nurse of the investigative team . The neuropsychologist will do the evaluation according to criteria common DSM5. Neuropsychologists now used DSM 5 criteria to diagnose delirium at our institution since new DSM 5 criteria have been published in French.

Secondary Outcomes

  • Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices(Day 0)

Study Sites (1)

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