Delirium Assessment in the Pediatric Intensive Care Unit

Pediatric Delirium Clinical Trial

— DIPI-ICU  

Official title:

Delirium Assessment in the Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416675
• Other study ID #: DIPI-ICU
• Status: Completed
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Pediatric Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Specifity of the Delirium Rating Scale (DRS)		The participants will be followed up in the sample period (1 to 21 days)
Secondary	Sensitivity of the Delirium Rating Scale (DRS)		The participants will be followed up in the sample period (1 to 21 days)
Secondary	Positive predictive value of the Delirium Rating Scale (DRS)		The participants will be followed up in the sample period (1 to 21 days)
Secondary	Prevalence of delirium	Measured with pediatric confusing assessment method for the intensive care unit (pCAM-ICU), Delirium Rating Scale (DRS) and DSM-IV-criteria	The participants will be followed up in the sample period (1 to 21 days)
Secondary	Depth of sedation	Measured with Richmond Agitation Sedation Scale (RASS)	The participants will be followed up in the sample period (1 to 21 days)
Secondary	Quality of Analgesia	Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.	The participants will be followed up in the sample period (1 to 21 days)