- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01416675
Delirium Assessment in the Pediatric Intensive Care Unit (DIPI-ICU)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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The participants will be followed up in the sample period (1 to 21 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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The participants will be followed up in the sample period (1 to 21 days)
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Specifity of the Delirium Rating Scale (DRS)
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
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The participants will be followed up in the sample period (1 to 21 days)
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Sensitivity of the Delirium Rating Scale (DRS)
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
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The participants will be followed up in the sample period (1 to 21 days)
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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)
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The participants will be followed up in the sample period (1 to 21 days)
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Prevalence of delirium
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
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Measured with pediatric confusing assessment method for the intensive care unit (pCAM-ICU), Delirium Rating Scale (DRS) and DSM-IV-criteria
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The participants will be followed up in the sample period (1 to 21 days)
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Depth of sedation
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
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Measured with Richmond Agitation Sedation Scale (RASS)
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The participants will be followed up in the sample period (1 to 21 days)
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Quality of Analgesia
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
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Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.
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The participants will be followed up in the sample period (1 to 21 days)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIPI-ICU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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