Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status (IDEAS)

This study is currently recruiting participants.
Verified December 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01720914
First received: October 30, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

In this prospective, multicenter observational study we assess the diagnostic validity of the following standard screening instruments for delirium regarding sedation, analgesia and ventilator status in critically ill patients:

  • Confusion Assessment Method for the ICU (CAM-ICU)
  • Intensive Care Delirium Screening Checklist (ICDSC)
  • Nursing-Delirium-Screening-Scale (Nu-DESC)

The definite delirium diagnosis (definite in terms of reference standard) is made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition, text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the Gold Standard to diagnose delirium.

Primary research question: Does sedation, ventilator status and analgesia influence the sensitivity of delirium screening tools (DST)?


Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Used reference standard: DSM-IV TR criteria

  • Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Used reference standard: DSM-IV TR criteria.

  • Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Used reference standard: DSM-IV TR criteria


Secondary Outcome Measures:
  • Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Used reference standard: DSM-IV-TR criteria.

  • Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]

    Calculation of positive and negative predictive values of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status.

    Used reference standard: DSM-IV-TR criteria


  • Incidence of delirium [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU)

  • Incidence of Subsyndromale Delirium (SSD) [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC)

  • Analgesia [ Time Frame: Participants will be followed in the 7-days sample period: ] [ Designated as safety issue: No ]
    According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI)

  • Ventilator status [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Clinical observation of A) whether an airway is used B)whether a patient is ventilated with a positive pressure ventilation or a high flow ventilation for more than 6 hours per day.

  • Administered neuroleptics, cumulative [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
  • Administered analgesics, cumulative [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
  • Administered sedatives, cumulative [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
  • Severity of illness [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA)

  • Antibiotics/infections [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Discharge mode [ Time Frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • 28-day mortality [ Time Frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Used reference standard: DSM-IV-TR criteria.

  • Sensitivity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia. [ Time Frame: Participants will be followed in the 7-days sample period ] [ Designated as safety issue: No ]
    Used reference standard: DSM-IV-TR criteria.


Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Critically ill patient

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Male and female adult critically ill patients

Criteria

Inclusion Criteria:

  • Critically ill patient
  • Patient age > 18 years

Exclusion Criteria:

  • Neurosurgical patients
  • Severe brain injury, intracerebral bleeding, stroke
  • Inability to communicate due to anacusia or severe hearing loss
  • Insufficient language comprehension
  • Patients < 24 h total time of Intensive Care Unit stay
  • Deep sedation (RASS < -3) for ≥ 7 days during study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720914

Contacts
Contact: Claudia Spies, MD Prof. +49 (0) 30 450 551 001 / 02 claudia.spies@charite.de

Locations
Brazil
Centro de Terapia Intensiva da Hospital Pro-Cardiaco Recruiting
Botafogo, Rio de Janeiro, Brazil, RJ 22280-020
Contact: Flávio E Nácul, MD PhD, MSc    +55 21 21311400    fnacul@uol.com.br   
Principal Investigator: Flávio E Nácul, MD, Prof.         
Germany
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité -University Medicine Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, MD, Prof.    +49 (0) 30 450 551 001 / 02    claudia.spies@charite.de   
Principal Investigator: Claudia Spies, MD, Prof.         
Sub-Investigator: Björn Weiss         
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01720914     History of Changes
Other Study ID Numbers: IDEAS
Study First Received: October 30, 2012
Last Updated: December 18, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014