DIPI-ICU: Delirium Assessment in the Pediatric Intensive Care Unit

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT01416675
Collaborator
(none)
68
1
6
11.3

Study Details

Study Description

Brief Summary

Objective: Studies documenting the prevalence of delirium among critically ill children are still rare. Emerging literature from psychiatric specialists reports the prevalence of delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely to be an underestimation of the true prevalence, as demonstrated in early adult delirium literature, especially given the absence of validated bedside tools to diagnose delirium in the PICU.

The primary aim of this study is to validate the German version of the Pediatric Confusion Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence Delirium (PAED) Scale.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    68 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Delirium Assessment in the Pediatric Intensive Care Unit
    Study Start Date :
    Jun 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU) [The participants will be followed up in the sample period (1 to 21 days)]

    Secondary Outcome Measures

    1. Specifity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU) [The participants will be followed up in the sample period (1 to 21 days)]

    2. Specifity of the Delirium Rating Scale (DRS) [The participants will be followed up in the sample period (1 to 21 days)]

    3. Sensitivity of the Delirium Rating Scale (DRS) [The participants will be followed up in the sample period (1 to 21 days)]

    4. Positive predictive value of the Delirium Rating Scale (DRS) [The participants will be followed up in the sample period (1 to 21 days)]

    5. Prevalence of delirium [The participants will be followed up in the sample period (1 to 21 days)]

      Measured with pediatric confusing assessment method for the intensive care unit (pCAM-ICU), Delirium Rating Scale (DRS) and DSM-IV-criteria

    6. Depth of sedation [The participants will be followed up in the sample period (1 to 21 days)]

      Measured with Richmond Agitation Sedation Scale (RASS)

    7. Quality of Analgesia [The participants will be followed up in the sample period (1 to 21 days)]

      Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • pediatric ICU patients
    Exclusion Criteria:
    • non-German-speaking

    • inability to communicate due to severe hearing loss or brain injury

    • preexisting psychosis

    • mental retardation due to a specific diseases (e.g. M. Crouzon, Kabuki Syndrome, Z.n. Battered Child, Atrogryposes multiplex congenita)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01416675
    Other Study ID Numbers:
    • DIPI-ICU
    First Posted:
    Aug 15, 2011
    Last Update Posted:
    May 10, 2021
    Last Verified:
    May 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 10, 2021