DeliriumNCT02481115
Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
An observational study of Delirium and Cognitive Impairment, run by Vanderbilt University.
Trial summary
The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Delirium, Cognitive Impairment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Oct 2014
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation
Who may be able to join
- All patients admitted to the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.
- Patients ventilated or non-ventilated.
Who cannot join
- Non-English speaking patients.
- Children with visual or hearing impairments.
- Patient/surrogate or physician refusal
- Moribund and not expected to survive >48 hours
- Patients in whom comfort care orders have been instituted
- Patients who are identified for transfer to floor or home regardless of placed orders or bed availability
About this study
Official title: Pediatric Delirium in Infants and Young Children: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. To test this hypothesis, the investigators will incorporate an instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation, and compare these assessments to those of the reference standard.
- Conditions
- Delirium, Cognitive Impairment
- Medical subject headings
- Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Children | Children in the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of psCAM-ICU
The investigators will validate the psCAM-ICU against a reference standard delirium assessment in critically ill infants and young children. Critical care physicians and registered nurses will use the psCAM-ICU to determine presence or absence of delirium once daily in critically ill infants and young children from 6 months to less than 5 years of age. The reference standard, a pediatric delirium expert (child psychiatrist or equivalent), will independently evaluate the same patients for presence or absence of delirium using the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) as the foundation of assessment.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (4)
Inter-rater reliability of diagnosing delirium
The investigators will assess inter-rater reliability between physician, practitioner, and nursing assessment using the psCAM-ICU. The psCAM-ICU should consistently diagnose delirium in the critically ill pediatric patient, independent of the type of medical care provider assessing the patient.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Validation of the Richmond Agitation Sedation Scale (RASS)
The investigators will validate the RASS against the Glasgow Coma Scale in critically ill infants and young children less than 5 years of age.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Validation of the Withdrawal Assessment Tool-1 (WAT-1)
The investigators will validate the WAT-1 against a reference standard (child psychiatrist) in critically ill infants and young children less than 5 years of age.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Long-term cognitive impairment composite
Clinical data will be obtained from the medical record to determine a composite measure of long-term cognitive impairment. The composite will include specific outcomes, and follow-up phone interviews with be conducted with a parent/legal guardian at 12 months post-hospital discharge of enrolled patients to assess cognitive function using a validated questionnaire that is compared to expected developmental trajectories based on age adjusted norms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startFeb 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi A. Beverley Smith, Vanderbilt University
- Investigators
- Heidi Smith, MD, Principal investigator, Vanderbilt University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481115
- Sponsor's protocol ID
- 121252
- Status last verified
- May 2017
- First submitted
- 18 Jun 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Delirium in Infants and Young Children: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
- ClinicalTrials.gov ID
- NCT02481115
- Acronym / sponsor ID
- 121252
- Conditions
- Delirium, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Jun 2015 (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.
The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. To test this hypothesis, the investigators will incorporate an instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation, and compare these assessments to those of the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Children | – | –Children in the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation
Key inclusion criteria (2 listed)
- All patients admitted to the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.
- Patients ventilated or non-ventilated.
Key exclusion criteria (6 listed)
- Non-English speaking patients.
- Children with visual or hearing impairments.
- Patient/surrogate or physician refusal
- Moribund and not expected to survive >48 hours
- Patients in whom comfort care orders have been instituted
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
Validation of psCAM-ICU
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The investigators will validate the psCAM-ICU against a reference standard delirium assessment in critically ill infants and young children. Critical care physicians and registered nurses will use the psCAM-ICU to determine presence or absence of delirium once daily in critically ill infants and young children from 6 months to less than 5 years of age. The reference standard, a pediatric delirium expert (child psychiatrist or equivalent), will independently evaluate the same patients for presence or absence of delirium using the Diagnostic and Statistical Manual of Mental Disorders (DSM IV-TR) as the foundation of assessment.
4 secondary outcomes
Inter-rater reliability of diagnosing delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Validation of the Richmond Agitation Sedation Scale (RASS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Validation of the Withdrawal Assessment Tool-1 (WAT-1)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Long-term cognitive impairment composite
Time frame: 1 year
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 2017.
- Individual participant dataSharing planned: No
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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.
Heidi Smith, MD principal investigator
Vanderbilt University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Cognitive Impairment, run by Vanderbilt University.
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 2 inclusion and 6 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 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Validation of psCAM-ICU (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 2017.