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STUDY OBJECTIVES: Observational data suggest pediatric intensive care unit-related sleep and circadian disruption (PICU-SCD) affects many critically ill children. Multi-center trials exploring PICU-SCD have been impractical as measuring sleep in this setting is challenging. This study validates a questionnaire for caregivers to describe children's sleep in the PICU. METHODS: This prospective, multi-center, case-control study enrolled caregivers of children in four PICUs or in a hospital-based sleep lab (controls). Survey items were compiled from validated adult ICU and pediatric in- and outpatient sleep questionnaires. Control responses were compared to polysomnography to determine accuracy. A score was calculated by summing the level of disruption of sleep timing, duration, efficiency, quality, and daytime sleepiness and irritability. RESULTS: In 152 PICU and 61 sleep lab caregivers, sleep survey items had acceptable internal reliability (α=0.75) and reproducibility on re-test surveys (ICC>0.600). Caregivers could not assess sleep of sedated children. Factor analysis identified three sub-scales of PICU-SCD. Control parents had good agreement with polysomnography sleep onset time (κ=0.823) and sleep onset latency (κ=0.707). There was a strong correlation between sleep scores derived by parental reporting to those by polysomnography (r=0.844, p<0.001). Scores had a linear association with caregiver-reported child sleep quality. There were no site-specific differences in sleep quality. Nearly all respondents found the survey easy to understand and of appropriate length. CONCLUSIONS: The SSqPICU provides a reliable, accurate description of inpatient sleep disruption in non-sedated children, generalizable across PICUs. It offers practical means to quantify PICU-SCD daily in future investigations.
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BACKGROUND: Over 50% of all critically ill children develop preventable intensive care unit-acquired morbidity. Early and progressive mobility is associated with improved outcomes in critically ill adults including shortened duration of mechanical ventilation and improved muscle strength. However, the clinical effectiveness of early and progressive mobility in the pediatric intensive care unit has never been rigorously studied. The objective of the study is to evaluate if the PICU Up! intervention, delivered in real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children. Additionally, the study aims to identify factors associated with reliable PICU Up! delivery. METHODS: The PICU Up! trial is a stepped-wedge, cluster-randomized trial of a pragmatic, interprofessional, and multifaceted early mobility intervention (PICU Up!) conducted in 10 pediatric intensive care units (PICUs). The trial's primary outcome is days alive free of mechanical ventilation (through day 21). Secondary outcomes include days alive and delirium- and coma-free (ADCF), days alive and coma-free (ACF), days alive, as well as functional status at the earlier of PICU discharge or day 21. Over a 2-year period, data will be collected on 1,440 PICU patients. The study includes an embedded process evaluation to identify factors associated with reliable PICU Up! delivery. DISCUSSION: This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and functional outcomes in critically ill children. This study will provide new and important evidence on ways to optimize short and long-term outcomes for pediatric patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04989790. Registered on August 4, 2021.