Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit

Not Applicable

Completed

• Conditions: Patients With Mental Confusion
• Interventions: Behavioral: CAM-ICU.fr

• Registration Number: NCT02760446
• Lead Sponsor: University Hospital, Montpellier

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-22
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAM-ICU.fr	CAM-ICU.fr	CAM-ICU and ICDSC evaluation proceed by two investigators and a Neuropsychologist (Speech \& language therapist specialized in neuropsychology)

Primary Outcome Measures

Name	Time	Method
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).	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 Outcome Measures

Name	Time	Method
Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices	Day 0	Statistics ICDSC criteria will be assessed against the Gold Standard . The reproducibility of the CAM- ICU and ICDSC will be evaluated according to different inter-observer.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Montpellier, Saint Eloi; 🇫🇷 Montpellier, Languedoc-Roussillon, France