Early Mobility Intervention for Critically Ill Children

(PICU Up! Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early mobilization of critically ill children during their stay in the Pediatric Intensive Care Unit (PICU) can improve recovery and reduce complications. The focus is on a program called PICU Up!, which encourages movement and involves better sleep and less sedation to aid faster recovery. Children who have been in the PICU for at least three days may qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care practices that could enhance recovery for future PICU patients.

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

Research shows that the "PICU Up!" program increases movement for children in the Pediatric Intensive Care Unit (PICU). Studies have found that early movement is safe and aids in better recovery. The program promotes activities like gentle exercises and sitting up, which are crucial for healing.

Previous research has demonstrated the program's safety and practicality. It aims to reduce the duration children need mechanical breathing support. This approach also seeks to decrease confusion and restlessness, known as delirium, which can occur during extended hospital stays.

Overall, studies strongly support the safety of the "PICU Up!" program. They suggest that facilitating safe movement in the PICU can enhance recovery without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PICU Up! program because it represents a proactive approach to improving recovery for critically ill children in intensive care units. Unlike the standard practice of bed rest, this program encourages early mobility, which can help in reducing the risk of muscle atrophy and promoting faster recovery. By implementing structured physical activity earlier in the treatment process, PICU Up! aims to enhance both physical and mental outcomes for young patients, potentially leading to shorter hospital stays and better long-term health.

What evidence suggests that the PICU Up! program is effective for early mobility in critically ill children?

Research has shown that the "PICU Up!" program, which encourages early movement for very sick children, can be helpful. Studies in adults have found that early movement can shorten time on breathing machines and reduce the risk of severe confusion, known as delirium. For children, early results suggest that the program is safe and can be implemented without major problems. By promoting early movement, "PICU Up!" aims to enhance children's recovery and prevent issues related to prolonged hospital stays. Although more research is needed to confirm these benefits in children, the program appears promising for improving their recovery. ^{1 2 3 5 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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. 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 ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10015670/

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