Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)

Cognitive Impairment Clinical Trial

Official title:

Pediatric Delirium in Infants and Young Children: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481115
• Other study ID #: 121252
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: May 8, 2017
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Confusion
• Delirium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	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.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	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.	1 year