CClinicalTrials.gg
CompletedNCT01416675DIPI-ICUUpdated May 10, 2021

Delirium Assessment in the Pediatric Intensive Care Unit

An observational study in Pediatric Delirium, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-05-10.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
68
Ages
5 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pediatric Delirium

Browse trials for

03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 68 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatric Intensive Care Unit Patients

Inclusion criteria

  • pediatric ICU patients

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
68 participants (actual)
06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Specifity of the Delirium Rating Scale (DRS)

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

  3. Sensitivity of the Delirium Rating Scale (DRS)

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

  4. 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)

  5. Prevalence of delirium

    Measured with pediatric confusing assessment method for the intensive care unit (pCAM-ICU), Delirium Rating Scale (DRS) and DSM-IV-criteria

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

  6. Depth of sedation

    Measured with Richmond Agitation Sedation Scale (RASS)

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

  7. Quality of Analgesia

    Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.

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

07

Study locations

1 site
  • Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin
    Berlin, 10117, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01416675
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Claudia Spies (Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, Germany) — Principal investigator
First posted
Aug 15, 2011
Start date
Jun 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
May 10, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion