Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

Study Overview
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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.

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.

Official Title
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Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

Conditions
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Pediatric Delirium

Intervention / Treatment
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* Diagnostic Test: SOS-PD


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of delirium in children aged 3 months -18 years of age | Delirium prevalence is determined by the proportion of patients that had at least one positive delirium score with patients that never had a positive delirium score determined by Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD). The minimum score of SOS-PD is 0 and maximum score is 17. The score ≥4 indicates delirium. | The observation period is 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD) assessment tool in to a Danish context. | The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value | The observation period is 24 hours |