Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

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

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-06-30

Brief Summary

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Pediatric delirium (PD) is a poorly investigated clinical problem that needs to be further explored in a Danish context. Children are at risk of discomfort and suffering if they experience delirium. The condition is associated with prolonged mechanical ventilation, longer hospital stay, increased mortality, and risk of long-term cognitive impairment. Therefore, it is important to assess critically ill children with a validated tool to enable early detection and management of the condition. In this study, the investigators will determine the prevalence of pediatric intensive care delirium. To this end, the investigators will validate the Sophia Observation withdrawal Symptoms - Pediatric delirium scale (SOS-PD) for patient assessment.

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Detailed Description

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Prospective prevalence and validation study of pediatric intensive care delirium.

Aim: To validate the SOS-PD assessment tool and determine the prevalence of delirium in children aged 3 months to 18 years in a Danish context.

Data analysis and power calculation: With 140 patients, the accuracy estimate in this study will have a 95% confidence interval of +/- 5%. Accuracy defined as (true positive + true negative) / all x 100 is expected to be 90%. The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value. The prevalence is calculated in percent. All data will be entered and encoded in RedCap and exported to SPSS for statistical analysis of data.

Conditions

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Pediatric Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SOS-PD

Validation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pediatric intensive care patients
* Length of stay of 48 hours or more

Exclusion Criteria

* Non Danish speaking
* Use of neuromuscular blocking agents
* sedation level at COMFORT behavior score \> 11 or Richmond Agitation Sedation Scale \> -3

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No