"PICU Up!" Early Mobility Intervention for Critically Ill Children
(PICU Up! Trial)
Trial Summary
What is the purpose of this trial?
While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the PICU Up! treatment for critically ill children?
Research suggests that early mobility interventions, like PICU Up!, can improve outcomes for critically ill children by reducing the time they need mechanical ventilation and enhancing their muscle strength and overall functional status. Similar approaches in adults have shown benefits, and early mobility in children may prevent complications like weakness and delirium, leading to better recovery.12345
Is the PICU Up! early mobility intervention safe for critically ill children?
The PICU Up! early mobility intervention is generally considered safe for critically ill children, with few complete contraindications (reasons to avoid the treatment). Appropriate precautions and preparation are recommended to address potential safety concerns, and perceived barriers to early mobilization are not linked to increased risk.12567
How is the PICU Up! treatment different from other treatments for critically ill children?
PICU Up! is unique because it focuses on early and progressive mobility for critically ill children in the pediatric intensive care unit (PICU), aiming to reduce the duration of mechanical ventilation and improve overall functional status. Unlike traditional care that often involves prolonged immobility, this treatment emphasizes individualized physical activities and play to enhance recovery and prevent complications.12489
Research Team
Sapna R Kudchadkar, MD
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for children in the PICU who have been on a breathing machine through their mouth or nose for at least 48 hours by the morning of their third day in care. It's not for kids if life support might be stopped soon, they have an open chest or abdomen, or are using ECMO (a heart-lung bypass machine).Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline/Pre-implementation
Usual PICU care is provided to establish baseline data before implementing the PICU Up! intervention
Intervention/Post-implementation
Implementation of the PICU Up! multifaceted, inter-professional pathway to optimize early and progressive patient mobility
Follow-up
Participants are monitored for safety and effectiveness after the intervention, including assessments of functional status and delirium
Treatment Details
Interventions
- PICU Up!
PICU Up! is already approved in United States for the following indications:
- Critically ill children requiring early mobility intervention to prevent PICU-acquired morbidities
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator