Pediatric DeliriumDIPI-ICUNCT01416675
Delirium Assessment in the Pediatric Intensive Care Unit
An observational study of Pediatric Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Pediatric Delirium
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric Intensive Care Unit Patients
Who may be able to join
- pediatric ICU patients
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin
Berlin, 10117
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)
Measured: 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)
Measured: The participants will be followed up in the sample period (1 to 21 days)
Specifity of the Delirium Rating Scale (DRS)
Measured: The participants will be followed up in the sample period (1 to 21 days)
Sensitivity of the Delirium Rating Scale (DRS)
Measured: The participants will be followed up in the sample period (1 to 21 days)
Positive predictive value of the Delirium Rating Scale (DRS)
Measured: The participants will be followed up in the sample period (1 to 21 days)
Prevalence of delirium
Measured with pediatric confusing assessment method for the intensive care unit (pCAM-ICU), Delirium Rating Scale (DRS) and DSM-IV-criteria
Measured: The participants will be followed up in the sample period (1 to 21 days)
Depth of sedation
Measured with Richmond Agitation Sedation Scale (RASS)
Measured: The participants will be followed up in the sample period (1 to 21 days)
Quality of Analgesia
Measured by Face Pain Scale, Revised (FPS-R) und the Numeric Analog Scale (NAS) or COMFORT Behavior-Scale.
Measured: The participants will be followed up in the sample period (1 to 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DeliriumStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416675
- Sponsor's protocol ID
- DIPI-ICU
- Acronym
- DIPI-ICU
- Status last verified
- May 2021
- First submitted
- 12 Aug 2011
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium Assessment in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01416675
- Acronym / sponsor ID
- DIPI-ICU / DIPI-ICU
- Conditions
- Pediatric Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric Intensive Care Unit Patients
Key inclusion criteria (1 listed)
- pediatric ICU patients
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
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)
Specifity of the Delirium Rating Scale (DRS)
Time frame: 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)
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)
Prevalence of delirium
Time frame: 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)
Quality of Analgesia
Time frame: The participants will be followed up in the sample period (1 to 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.