Overview

This trial is active, not recruiting.

Conditions delirium, cognitive impairment
Sponsor Vanderbilt University
Start date February 2013
End date October 2014
Trial size 300 participants
Trial identifier NCT02481115, 121252

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Children in the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.

Primary Outcomes

Measure
Validation of psCAM-ICU
time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 6 months up to 5 years old.

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

Additional Information

Official title Pediatric Delirium in Infants and Young Children: Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Principal investigator Heidi Smith, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.