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Clinical Trials/NCT01416675
NCT01416675
Completed
Not Applicable

Delirium Assessment in the Pediatric Intensive Care Unit

Charite University, Berlin, Germany1 site in 1 country68 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Delirium
Sponsor
Charite University, Berlin, Germany
Enrollment
68
Locations
1
Primary Endpoint
Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
December 2011
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin

Charite University, Berlin, Germany

Eligibility 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)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Specifity of the Delirium Rating Scale (DRS)(The participants will be followed up in the sample period (1 to 21 days))
  • 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))
  • Quality of Analgesia(The participants will be followed up in the sample period (1 to 21 days))
  • Sensitivity of the Delirium Rating Scale (DRS)(The participants will be followed up in the sample period (1 to 21 days))
  • Positive predictive value of the Delirium Rating Scale (DRS)(The participants will be followed up in the sample period (1 to 21 days))
  • Depth of sedation(The participants will be followed up in the sample period (1 to 21 days))
  • Prevalence of delirium(The participants will be followed up in the sample period (1 to 21 days))

Study Sites (1)

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