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

NCT02481115 | Completed

• 1 other identifier: 121252
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Inter-rater reliability of diagnosing delirium

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Validation of the Richmond Agitation Sedation Scale (RASS)

  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)

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Long-term cognitive impairment composite

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Heidi Smith, MD

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 25, 2015
• Study Start: February 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share