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

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, inter-professional 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.

ClinicalTrials.gov Identifier: NCT04989790

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

InstitutionHospital NameSite PI
Baylor College of MedicineTexas Children's HospitalMatthew Musick, MD
Geisel School of Medicine at Dartmouth CollegeChildren's Hospital at DartmouthKelly Corbett, MD
Geisinger Commonwealth School of MedicineJanet Weis Children's HospitalElizabeth Scarlett, MD
Medical College of WisconsinChildren's Hospital of WisconsinCharles Rothschild, MD
Stanford UniversityValley Children's HospitalMolly Dorfman, MD, MPH
University of Central FloridaNemours Children's HospitalMashael Alqahtani, MBBS, MS
University of LouisvilleNorton Children's HospitalJohn Berkenbosch, MD
University of MinnesotaHennepin HealthcareAndrew Kiragu, MD
University of North CarolinaUNC Children's HospitalTracie Walker, MD
West Virginia UniversityWVU Medicine Children's HospitalMel Wright, DO

Principal Investigator & Clinical Coordinating Center Chair: Sapna Kudchadkar, MD, PhD ([email protected]

Data Coordinating Center Chair: Dale Needham, MD, PhD

Clinical Coordinating Center Project Manager: Colleen Mennie, RN ([email protected])

Data Coordinating Center Manager: Victor Dinglas, MPH

Azamfirei R, Mennie C, Dinglas VD, Fatima A, Colantuoni E, Gurses AP, Balas MC, Needham DM, Kudchadkar SR; on behalf of the PICU Up! Investigators. Impact of a multifaceted early mobility intervention for critically ill children - the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial. Trials. 2023 Mar 15;24(1):191. PubMed | Article