Delirium Assessment in the Pediatric Intensive Care Unit (DIPI-ICU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01416675
First received: August 12, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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
Pediatric Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Delirium Assessment in the Pediatric Intensive Care Unit

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU) [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specifity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU) [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
  • Specifity of the Delirium Rating Scale (DRS) [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
  • Sensitivity of the Delirium Rating Scale (DRS) [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
  • Positive predictive value of the Delirium Rating Scale (DRS) [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
  • Prevalence of delirium [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
    Measured with pediatric confusing assessment method for the intensive care unit (pCAM-ICU), Delirium Rating Scale (DRS) and DSM-IV-criteria

  • Depth of sedation [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
    Measured with Richmond Agitation Sedation Scale (RASS)

  • Quality of Analgesia [ Time Frame: The participants will be followed up in the sample period (1 to 21 days) ] [ Designated as safety issue: No ]
    Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.


Enrollment: 73
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pediatric Intensive Care Unit Patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416675

Locations
Germany
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
  More Information

No publications 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     History of Changes
Other Study ID Numbers: DIPI-ICU
Study First Received: August 12, 2011
Last Updated: June 5, 2014
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 July 22, 2014