Delirium Assessment in the Pediatric Intensive Care Unit (DIPI-ICU)

May 7, 2021 updated by: Claudia Spies, Charite University, Berlin, Germany

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pediatric Intensive Care Unit Patients

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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)
The participants will be followed up in the sample period (1 to 21 days)
Specifity of the Delirium Rating Scale (DRS)
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
The participants will be followed up in the sample period (1 to 21 days)
Sensitivity of the Delirium Rating Scale (DRS)
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
The participants will be followed up in the sample period (1 to 21 days)
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)
The participants will be followed up in the sample period (1 to 21 days)
Prevalence of delirium
Time Frame: 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
The participants will be followed up in the sample period (1 to 21 days)
Depth of sedation
Time Frame: The participants will be followed up in the sample period (1 to 21 days)
Measured with Richmond Agitation Sedation Scale (RASS)
The participants will be followed up in the sample period (1 to 21 days)
Quality of Analgesia
Time Frame: 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.
The participants will be followed up in the sample period (1 to 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 12, 2011

First Submitted That Met QC Criteria

August 12, 2011

First Posted (ESTIMATE)

August 15, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

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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