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Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol
Razvan Azamfirei1,2, Colleen Mennie1, Victor D Dinglas3,4
1Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Insights
Early mobility interventions in pediatric intensive care units (PICUs) can reduce mechanical ventilation duration and improve outcomes for critically ill children. This study evaluates the PICU Up! intervention
Area of Science:
- Critical Care Medicine
- Pediatric Intensive Care
- Rehabilitation
Background:
- Over 50% of critically ill children experience preventable intensive care unit-acquired morbidity.
- Early and progressive mobility improves outcomes in adult critical care but remains understudied in pediatric intensive care units (PICUs).
- The PICU Up! intervention aims to address this gap by promoting early mobility in critically ill children.
Purpose of the Study:
- To evaluate the effectiveness of the PICU Up! intervention in reducing mechanical ventilation duration in critically ill children.
- To assess the impact of the PICU Up! intervention on delirium and functional status in pediatric intensive care patients.
- To identify factors associated with the reliable delivery of the PICU Up! intervention in real-world settings.
Main Methods:
- A stepped-wedge, cluster-randomized trial involving 10 pediatric intensive care units (PICUs).
- The study will enroll 1,440 pediatric patients over a 2-year period.
- Primary outcome: days alive free of mechanical ventilation; Secondary outcomes: delirium- and coma-free days, functional status.
Main Results:
- This section is to be filled once the study results are available.
Conclusions:
- This study will provide crucial evidence on the impact of a multifaceted early mobility strategy on mechanical ventilation duration, delirium, and functional outcomes in critically ill children.
- Findings will inform optimized care strategies for improving short- and long-term outcomes in pediatric intensive care patients.
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.
