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

Patients With Mental Confusion Clinical Trial

— CAM-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760446
• Other study ID #: 9596
• Status: Completed
• Phase: N/A
• First received: December 22, 2015
• Last updated: November 17, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Confusion
• Consciousness Disorders
• Patients With Mental Confusion

Intervention

Behavioral:
• CAM-ICU.fr
Neuropsychological testing

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Montpellier, Saint Eloi	Montpellier	Languedoc-Roussillon

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Vanderbilt University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	Day 0	No
Secondary	Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices	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.	Day 0	No