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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02760446

Acronym

CAM-ICU

Enrollment

115

Registered

2016-05-03

Start date

2015-11-30

Completion date

2016-04-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Mental Confusion

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)

Interventions

BEHAVIORALCAM-ICU.fr

Neuropsychological testing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026