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Completed

NCT Number: NCT01416675

Delirium Assessment in the Pediatric Intensive Care Unit

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.

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Key information

Conditions

Pediatric Delirium

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

    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

  6. 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)

  7. 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: DIPI-ICU

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 15, 2011
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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