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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:
Sponsor: Vanderbilt University

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inter-rater reliability of diagnosing delirium [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    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.
  • 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 ]
    The investigators will validate the RASS against the Glasgow Coma Scale in critically ill infants and young children less than 5 years of age.
  • 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 ]
    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.
  • Long-term cognitive impairment composite [ Time Frame: 1 year ]
    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.


Original Secondary Outcome: Same as current

Information By: Vanderbilt University Medical Center

Dates:
Date Received: June 18, 2015
Date Started: February 2013
Date Completion:
Last Updated: May 8, 2017
Last Verified: May 2017