Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial

What this Trial Is About

Researchers are evaluating the effectiveness of the PICU Up! intervention, a multifaceted early mobility program, for critically ill children in pediatric intensive care units (PICUs). The study aims to see if this approach can reduce the duration of mechanical ventilation and improve delirium and functional outcomes compared to usual care. The trial focuses on children at risk of functional decline, particularly those on mechanical ventilation, addressing challenges such as sedation, delirium, and immobility that affect recovery. The PICU Up! intervention integrates goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily care. It uses a tiered activity plan tailored to each child's needs, with the care team setting daily mobility goals during rounds. The intervention includes analgesia management, extubation readiness testing, sedation and delirium monitoring, early physical and occupational therapy consultation by PICU Day 3, sleep support, and family involvement. The study compares usual PICU care with this structured intervention across multiple hospitals. Participants will be critically ill children requiring invasive mechanical ventilation for at least 48 hours by PICU Day 3. Researchers will assess mechanical ventilation duration, delirium days, and functional status changes using standardized pediatric scales through Day 21. The study also includes a process evaluation to understand factors affecting intervention delivery. Participants' care, safety, and outcomes will be closely monitored throughout the trial, which is expected to continue until 2026.

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children