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Completed

NCT Number: NCT02481115

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 25, 2015
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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