Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04774211
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2021-02-22
Brief Title:
Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None