Delirium Assessment in the Pediatric Intensive Care Unit

NCT01416675 | Completed

• 1 other identifier: DIPI-ICU
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• Specifity of the Delirium Rating Scale (DRS)

  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)

• Prevalence of delirium

  The participants will be followed up in the sample period (1 to 21 days)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric Intensive Care Unit Patients

You may qualify if:

• pediatric ICU patients

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 10117, Germany

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

DE (1)