Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.
Study Details
Study Description
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 and involve the parents of the patients in the delirium detection.
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Detailed Description
Prospective prevalence and validation study of pediatric intensive care delirium.
Aim: To investigate the prevalence and duration of delirium in children aged 3 months-18 years of age using parent involvement in assessment of the child.
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Translation of the SOS-PD tool according to principles of good practice for the translation and cultural adaptation process for patient-reported outcomes
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Training healthcare professionals to use SOS-PD at five hospital units. To ensure the understanding of SOS-PD short interviews will be performed in a random sampling.
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Validation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard (n=140)
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Training parents in delirium screening using the SOS-PD at three hospital units (5021, 5061, 4144). To ensure the understanding of SOS-PD short interviews will be performed.
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. Interrater reliability between the nurse / parent, the nurse / reference standard, and the parents / reference standard's SOS-PD score will be calculated with linearly weighted Cohen kappa value. Cohen's kappa value> 0.65 is considered satisfactory. To compare the mean values of the SOS-PD score between parents and nurses, the student's t-test is used. P. value of <0.05 is considered statistically significant. 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 Design
Outcome Measures
Primary Outcome Measures
- Prevalence of delirium in children aged 3 months -18 years of age [Participants will be followed for the duration of hospital stay assessed up to 14 days]
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.
Secondary Outcome Measures
- Validation of the Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD) assessment tool in to a Danish context. [Participants will be followed for the duration of hospital stay assessed up to 14 days]
The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value
- Duration of delirium in children aged 3 months - 18 years [Participants will be followed for the duration of hospital stay assessed up to 14 days]
Delirium duration is determined by the first positive delirium score to the first negative delirium score determined by SOS-PD.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pediatric intensive care patients
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Length of stay of 48 hours or more
Exclusion Criteria:
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Non Danish speaking
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Use of neuromuscular blocking agents
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sedation level at COMFORT behavior score > 11 or Richmond Agitation Sedation Scale > -3
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- Novo Nordisk A/S
Investigators
- Principal Investigator: Ingrid Egerod, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NNF20OC0066074