NCT04774211

Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 141 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: —

Summary

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

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

• Pediatric Delirium

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-03-01
• Last updated: 2022-08-31

Locations

1 site across 1 country: Denmark