Delirium Assessment in the Pediatric Intensive Care Unit

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01416675

Acronym

DIPI-ICU

Enrollment

Registered

2011-08-15

Start date

2011-06-30

Completion date

2011-12-31

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Delirium

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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)	—
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)	—
Depth of sedation	The participants will be followed up in the sample period (1 to 21 days)	Measured with Richmond Agitation Sedation Scale (RASS)
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.
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

Countries

Germany

Outcome results