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Completed

NCT Number: NCT02760446

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

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)

Completed

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Key information

Conditions

Patients With Mental Confusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAM-ICU.fr

Behavioral

Neuropsychological testing

Primary outcomes

  1. 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

  1. Inter-rater reliability, comparison to Intensive Care Delirium Screening Checklist and standard bedside practices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Vanderbilt University

Registry information

Official study title

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

Acronym: CAM-ICU

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 3, 2016
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.