Delirium Assessment in the Pediatric Intensive Care Unit

Completed

• Conditions: Pediatric Delirium

• Registration Number: NCT01416675
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.
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)	Measured with Richmond Agitation Sedation Scale (RASS)
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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany