"PICU Up!" Early Mobility Intervention for Critically Ill Children

(PICU Up! Trial)

Recruiting at 10 trial locations

Overseen By Colleen Mennie, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Withdrawal of life support, ECMO, others

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

1440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called PICU Up! to help critically ill children recover better in intensive care. The goal is to determine if early movement and other supportive practices can shorten the time children need ventilator support and improve their overall health. Children who have used a ventilator for at least two days might be suitable for this trial. The study compares usual care to the new method to identify which is more effective. As an unphased trial, this study provides a unique opportunity to contribute to innovative care practices that could enhance recovery for critically ill children.

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 prior data suggests that the PICU Up! intervention is safe for critically ill children?

Research has shown that the PICU Up! program has been safely and successfully tested in both small and large studies. This program helps critically ill children in the Pediatric Intensive Care Unit (PICU) increase their movement, starting early and progressing gradually. The studies found that this approach can be implemented without major safety issues. It involves managing sedation, preventing confusion, promoting sleep, and involving families. Previous trials have reported no serious problems. So far, evidence suggests that PICU Up! is well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "PICU Up!" early mobility intervention because it aims to change how we care for critically ill children in the Pediatric Intensive Care Unit (PICU). Unlike standard care, which often involves prolonged bed rest, "PICU Up!" integrates early and progressive mobility into routine care, involving a team of healthcare professionals to safely encourage movement. This approach hopes to improve recovery times and overall outcomes by getting children moving sooner, potentially reducing the negative effects of long-term immobility.

What evidence suggests that the PICU Up! intervention is effective for improving outcomes in critically ill children?

Research has shown that getting critically ill adults moving early can lead to better health outcomes. For these adults, starting movement sooner reduces the time they need breathing machines and helps prevent muscle weakness. Although few studies focus on critically ill children, early tests of the PICU Up! program, which participants in this trial may receive, have shown it is safe and feasible. The PICU Up! program employs several methods, such as managing sedation, preventing confusion, and promoting sleep, to help children start moving earlier. Initial results suggest this approach could reduce the time children need ventilators and improve their recovery. This strategy might lead to better health outcomes for children in intensive care. ^{1 2 3 4 5}

Who Is on the Research Team?

Sapna R Kudchadkar, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

I have been on a breathing machine for more than 48 hours.

Exclusion Criteria

You are currently on life support or expected to be taken off life support within 48 hours.

You are currently using Extracorporeal Membrane Oxygenation (ECMO).

I have had an open chest or abdomen surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline/Pre-implementation

Usual PICU care is provided to establish baseline data before implementing the PICU Up! intervention

3 weeks

Continuous monitoring in PICU

Intervention/Post-implementation

Implementation of the PICU Up! multifaceted, inter-professional pathway to optimize early and progressive patient mobility

3 weeks

Continuous monitoring in PICU

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessments of functional status and delirium

3 weeks

Regular assessments in PICU

What Are the Treatments Tested in This Trial?

Interventions

• PICU Up!

Trial Overview The 'PICU Up!' intervention is being tested to see if it can reduce how long critically ill children need mechanical ventilation. It combines managing sedation, preventing delirium, promoting sleep, and involving families to help these kids start moving sooner and more safely.

How Is the Trial Designed?

Group I: Baseline/Pre-implementation Active Control 1 Intervention

Usual PICU care

Group II: Intervention/Post-implementation Active Control 1 Intervention

PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.

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+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

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 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]

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]

A group of 10 experts developed consensus recommendations for safe early mobilization (EM) in critically ill children to reduce morbidities associated with prolonged immobility in the pediatric intensive care unit (PICU).

The recommendations emphasize that EM should be part of a comprehensive rehabilitation care plan, tailored to each child's needs, and initiated early to optimize recovery and functional mobility, despite limited existing pediatric evidence on its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice Recommendations for Early Mobilization in Critically Ill Children. Choong, K., Canci, F., Clark, H., et al.[2023]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36918956/

the PICU Up! trial: study protocol for a multicenter ... - PubMed This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04989790

Clinical Effectiveness of the "PICU Up!" Multifaceted Early ... If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07206-2

Impact of a multifaceted early mobility intervention for critically ... This study will examine whether a multifaceted strategy to optimize early mobility affects the duration of mechanical ventilation, delirium incidence, and ...

4. journals.lww.com journals.lww.com/ccmjournal/fulltext/2024/01001/12__the_picu_up__pilot_trial__feasibility_and.14.aspx

12: the picu up! pilot trial: feasibility and impact of an early ... This pilot study aims to evaluate the feasibility of implementing the PICU Up! intervention and its impact on the duration of mechanical ventilation in PICU ...

5. digitalcommons.unmc.edu digitalcommons.unmc.edu/cgi/viewcontent.cgi?article=1001&context=con_nnrc_articles

Impact of a Multifaceted Early Mobility Intervention for Critically ... Early and progressive mobility is associated with improved outcomes in critically ill adults including shortened duration of mechanical ventilation and improved ...