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

NCT ID: NCT02481115

Last Updated: 2017-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-10-31

Brief Summary

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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 Description

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Conditions

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Delirium Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Heidi A. Beverley Smith

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Other Identifiers

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121252

Identifier Type: -

Identifier Source: org_study_id

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