Early Mobility Intervention for Critically Ill Children

(PICU Up! Trial)

Recruiting at 1 trial location

Overseen By Ronke Awojoodu, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Active DNR order

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

2500 Participants Needed

Trial Summary

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 focuses on early mobility for critically ill children, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment PICU Up! for critically ill children?

Research suggests that early mobility interventions like PICU Up! can improve outcomes for critically ill children by reducing the duration of mechanical ventilation and enhancing muscle strength, similar to benefits seen in adults. Additionally, implementing early mobility protocols has been associated with improved functional status and increased orders for physical, occupational, and speech therapy, indicating better recovery and quality of life after discharge. ^{1 2 3 4 5}

Is early mobility intervention safe for critically ill children in the PICU?

Early mobility interventions in the PICU are generally considered safe for critically ill children when appropriate precautions are taken. Although there are some concerns about safety, these can be managed with careful planning and collaboration among healthcare providers. ^{1 2 4 6 7}

How is the PICU Up! treatment different from other treatments for critically ill children?

The PICU Up! treatment is unique because it focuses on early and progressive mobility for critically ill children in the pediatric intensive care unit (PICU), aiming to improve outcomes like reduced mechanical ventilation duration and better functional status. Unlike traditional approaches that often involve sedation and immobilization, this treatment emphasizes individualized physical activities and play to enhance recovery and quality of life. ^{1 2 4 8 9}

What is the purpose of this trial?

Recent decreases in Pediatric Intensive Care Unit (PICU) mortality rates have been offset by increased morbidity and length of stay for vulnerable young patients. Heavy sedation, bedrest, and delirium contribute to a PICU culture of immobility. While studies in adult ICU patients demonstrate the clinical benefits of early mobilization, fewer than 25% of critically ill children mobilize early in the children's PICU stay. The investigators have demonstrated the safety and feasibility of the 'PICU Up!' Mobility Program, which integrates sleep promotion, delirium prevention, sedation optimization as a bundle to increase mobilization. However, the generalizability and broader impact on patient- and family-centered outcomes is unknown. Therefore, there is an urgent need for trials that blend both clinical effectiveness and implementation research to create a PICU culture of mobility and improve the value of PICU care. The overall objective of the proposed research is to determine the impact of a transdisciplinary and multifaceted early mobility program on clinical outcomes and ICU-acquired morbidities in critically ill children. Additionally, the investigators will identify barriers and facilitators to high-performance bundle adoption.

Research Team

Sapna R Kudchadkar, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for critically ill children in PICUs that haven't started a mobility program. It's open to all patients admitted, but only those staying 3 days or more are included in the data analysis. Children with an active do-not-resuscitate (DNR) order are excluded.

Inclusion Criteria

I have been in the PICU for 3 days or more.

Participating PICUs must be a separate physical space dedicated to the care of critically ill infants and children, with the ability to provide mechanical ventilation.

My PICU has not started a mobility protocol and will not start one until the study says.

Exclusion Criteria

Patients with an active do-not-resuscitate (DNR) order will be excluded.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Usual Care

Each unit begins in the baseline, usual care phase before implementing the PICU Up! program

4 weeks

PICU Up! Implementation

Implementation of the PICU Up! program, which includes early mobility interventions, sleep promotion, delirium prevention, and sedation optimization

4 weeks

Post-implementation

Phase following the implementation of the PICU Up! program to assess its impact

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PICU Up!

Trial Overview 'PICU Up!' is being tested; it's a program combining sleep promotion, delirium prevention, and sedation optimization to encourage early mobilization of young patients in the PICU to improve their recovery and reduce ICU-acquired issues.

Participant Groups

Group I: PICU Up! pre- and post-implementation Experimental Treatment 1 Intervention

Each unit will begin in the baseline, usual care phase and then be randomized to implement the PICU Up! program during a set time period, followed by the post-implementation phase.

PICU Up! is already approved in United States for the following indications:

Approved in United States as PICU Up! for:

• Critically ill children requiring early mobility intervention to prevent PICU-acquired morbidities

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Donaghue Medical Research Foundation

Collaborator

Trials

24

Recruited

578,000+

Findings from Research

Introducing early mobility programs in the pediatric intensive care unit (PICU) can help prevent complications like weakness and delirium in critically ill children, improving their overall outcomes.

A structured, interdisciplinary approach to early mobilization, tailored to each child's individual needs and conditions, is essential for safely implementing these programs and enhancing recovery after PICU discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a culture of early mobilization in the pediatric intensive care unit-a nuts and bolts approach. Morrow, BM.[2021]

The PICU Up! trial is a large-scale study involving 1,440 critically ill children across 10 pediatric intensive care units, aiming to assess the impact of an early mobility intervention on reducing the duration of mechanical ventilation and improving overall functional status.

This study will provide valuable insights into whether early and progressive mobility can enhance recovery outcomes in critically ill children, potentially reducing complications like delirium and improving long-term health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Azamfirei, R., Mennie, C., Dinglas, VD., et al.[2023]

The PICU Up! program, aimed at early mobilization of patients, has been positively received by staff at Johns Hopkins Hospital, enhancing role satisfaction and team dynamics three years post-implementation.

Despite its success, challenges such as resource management, sedation decisions, and patient diversity hinder consistent execution of the program, highlighting the need for ongoing stakeholder engagement and tailored solutions to sustain mobility initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Mobilization in a PICU: A Qualitative Sustainability Analysis of PICU Up! Patel, RV., Redivo, J., Nelliot, A., et al.[2023]

Implementing an early mobility protocol in the pediatric Intensive Care Unit (PICU) significantly increased the likelihood of patients receiving physical therapy orders, rising from 47% to 79% in 2020 compared to 2019.

The protocol also led to a higher daily incidence of mobility activities (4.88 vs 4.1), but it did not result in improved functional status scores at discharge or three months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Intensive Care Unit Early Mobility Program: Impact on Patient Functional Status. Rogers, T., Stram, D., Fort, V., et al.[2023]

A study analyzing 4658 mobility events in pediatric intensive care units (PICUs) found that early mobilization has a strong safety profile, with only a 4% rate of potential safety events, mostly consisting of transient physiological changes.

Medical equipment dislodgement was very rare (0.3%), and no serious incidents like falls or cardiac arrests occurred, although patients with delirium had higher potential safety event rates, indicating the need for better screening and education for healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobilization Safety of Critically Ill Children. LaRosa, JM., Nelliot, A., Zaidi, M., et al.[2023]

In a national study of 13 pediatric intensive care units (PICUs) in Canada, 80% of patient days involved mobilization activities, demonstrating that mobilization is common and safe, even for children who are intubated and mechanically ventilated.

Family involvement significantly enhances out-of-bed mobility, with an odds ratio of 6.4, indicating that engaging families in rehabilitation practices can help overcome barriers to mobilization in PICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Acute Rehabilitation for Kids in the PICU: A Canadian Multicenter Point Prevalence Study. Choong, K., Zorko, DJ., Awojoodu, R., et al.[2023]

The implementation of ICU-based mobility guidelines for critically ill children led to a significant increase in physical and occupational therapy consultations, rising from 17% to 81.5% within 72 hours post-implementation.

Despite the increase in consultations, the actual number of therapy sessions did not improve due to high deferral rates, indicating that barriers such as patient sedation and severity of illness need to be addressed in future guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of Pediatric ICU-based Mobility Guidelines: A Quality Improvement Initiative. Ames, SG., Alessi, LJ., Chrisman, M., et al.[2022]

Early mobilization in pediatric intensive care units is crucial as it is the only evidence-based intervention that can reduce ICU-acquired weakness and delirium, yet its implementation faces significant barriers.

This scoping review aims to identify and map the literature on these barriers and enablers, focusing on programs for children and youth aged 0-18 in pediatric ICUs, to improve the uptake of early mobility practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and enablers to the development and implementation of early mobility programs for children in the pediatric intensive care unit: a scoping review protocol. Thompson, S., Cassidy, C., McKibbon, S., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

Building a culture of early mobilization in the pediatric intensive care unit-a nuts and bolts approach. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Early Mobilization in a PICU: A Qualitative Sustainability Analysis of PICU Up! [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pediatric Intensive Care Unit Early Mobility Program: Impact on Patient Functional Status. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Quality Improvement Methodology to Optimize Safe Early Mobility in a Pediatric Intensive Care Unit. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Mobilization Safety of Critically Ill Children. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Acute Rehabilitation for Kids in the PICU: A Canadian Multicenter Point Prevalence Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Development and Implementation of Pediatric ICU-based Mobility Guidelines: A Quality Improvement Initiative. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Barriers and enablers to the development and implementation of early mobility programs for children in the pediatric intensive care unit: a scoping review protocol. [2023]