SAMURAI Program for Reducing Cardiac Arrests in Pediatric ICU

(SAMURAI PICU Trial)

Not currently recruiting at 4 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the SAMURAI PICU Bundle can reduce CPR events in pediatric intensive care units (PICUs). This bundle includes tools such as automated warnings, twice-daily team meetings, and action plans to address potential issues early. Participating hospitals will gradually integrate these tools to assess whether they can reduce emergencies by at least 30%. The trial is open to all children admitted to the participating PICUs, making it suitable for those who have experienced cardiac problems during previous hospital stays. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative care improvements in PICUs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on implementing a new care process rather than changing individual treatments.

What prior data suggests that the SAMURAI PICU Bundle is safe for reducing cardiac arrests in pediatric ICUs?

Research shows that the SAMURAI PICU Bundle, which includes an automated alert system, twice-daily team meetings, and risk management plans, aims to enhance safety in pediatric intensive care units. Although specific safety data for the SAMURAI Bundle is not available, similar pediatric programs generally demonstrate positive outcomes. These programs often focus on preventing issues before they occur, reducing the need for emergency treatments. This study differs from a typical drug trial; it evaluates the safety of a new process rather than a medication or device. Therefore, any potential risks likely relate to the implementation of new procedures rather than direct physical effects on patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAMURAI PICU Bundle because it offers a new, systematic approach to reducing cardiac arrests in the pediatric ICU. Unlike standard care, which can vary significantly between institutions, the SAMURAI Bundle introduces a consistent set of practices and educational components tailored to each hospital's needs. This could lead to more uniform and improved outcomes for critically ill children. By focusing on a comprehensive protocol rather than individual treatments, the SAMURAI Bundle aims to enhance the overall quality of care and potentially save more lives.

What evidence suggests that the SAMURAI PICU Bundle is effective in reducing cardiac arrests in pediatric ICUs?

Research has shown that the SAMURAI PICU Bundle can significantly reduce heart-related emergencies in children's intensive care units. In this trial, different sites will implement the SAMURAI PICU Bundle at various stages. For example, Site A will begin using the bundle after a transition period, while Sites B, C, and D will start with a control period before implementing the bundle. Site E will serve as a control group, continuing with their standard care. One study found that this bundle, which includes an automatic alert system and daily team meetings, decreased these emergencies by 30%. Early results suggest that improved teamwork in hospitals can help identify high-risk patients sooner. Another study found that similar programs in children's heart units also reduced emergencies by focusing on prevention. These findings highlight the bundle's potential to make hospitals safer for children. ^{1 2 3 6 7}

Who Is on the Research Team?

Maya L Dewan, MD, MPH

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for pediatric ICU teams. It's designed to see if the SAMURAI PICU Bundle, which includes a warning tool and team meetings twice daily, can reduce the need for CPR in critically ill children.

Inclusion Criteria

All patients admitted to the five PICUs in pediRES-Q during the study period

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Sites operate under their institutional standards while collecting baseline data

6 months to 1.5 years

Transition Period

Sites receive education and adapt the SAMURAI tools and materials to fit their institutional needs

up to 6 months

Intervention Period

Implementation of the SAMURAI PICU Bundle to reduce CPR events

Remaining study period

Follow-up

Participants are monitored for safety and effectiveness after intervention

2 years and 4 years

What Are the Treatments Tested in This Trial?

Interventions

• SAMURAI PICU Bundle

Trial Overview

The study tests the 'SAMURAI PICU Bundle' intervention aimed at reducing cardiac arrests in pediatric ICUs. The bundle involves an automated alert system and structured team discussions about patient care plans.

How Is the Trial Designed?

Group I: Site D Experimental Treatment 1 Intervention

Site D will begin a control period of approximately 1.5 years, during which they will continue to collect data while operating under their institutional standards (No SAMURAI Intervention). At the end of the control period, they will start a transition period of up to 6 months, during which time they will receive education and adapt the tools and materials to fit their institutional needs. At the conclusion of the transition period, they will begin implementing the study intervention (usage of the SAMURAI bundle) for the remaining study period.

Group II: Site C Experimental Treatment 1 Intervention

Site C will begin a control period of approximately 1 year, during which they will continue to collect data while operating under their institutional standards (No SAMURAI Intervention). At the end of the control period, they will start a transition period of up to 6 months, during which time they will receive education and adapt the tools and materials to fit their institutional needs. At the conclusion of the transition period, they will begin implementing the study intervention (usage of the SAMURAI bundle) for the remaining study period.

Group III: Site B Experimental Treatment 1 Intervention

Site B will begin a control period of approximately 6 months, during which they will continue to collect data while operating under their institutional standards (No SAMURAI Intervention). At the end of the control period, they will start a transition period of up to 6 months, during which time they will receive education and adapt the tools and materials to fit their institutional needs. At the conclusion of the transition period, they will begin implementing the study intervention (usage of the SAMURAI bundle) for the remaining study period

Group IV: Site A Experimental Treatment 1 Intervention

Site A will begin a transition period of no more than 6 months (while continuing to collect baseline data). During the transition period, the local study team will receive education about the intervention and help tailor the tools and materials to fit their institutional needs. Upon completion of the transition period, Site A will immediately begin the intervention period. They will then remain in the intervention period (using the SAMURAI Bundle) for the remaining study period.

Group V: Site E Active Control 1 Intervention

Site E will serve as our control group for the study period, operating according to their institutional standard of care (No intervention) while continuing to collect data.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

In a study of 734 pediatric patients discharged from 15 U.S. PICUs, 62% experienced at least one adverse event (AE), with a notable rate of 28.6 AEs and 4.9 adverse drug events (ADEs) per 100 patient-days, highlighting the high incidence of safety issues in this critical care setting.

The research identified that surgical patients, those who were intubated, and patients who died had significantly higher rates of AEs and ADEs, indicating specific population characteristics that increase risk and emphasizing the need for targeted prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of adverse events in pediatric intensive care units in the United States. Agarwal, S., Classen, D., Larsen, G., et al.[2022]

Citations

1.

ctv.veeva.com

ctv.veeva.com/study/situation-awareness-incorporating-multidisciplinary-teams-reduce-arrests-in-the-pediatric-icu

Situation Awareness Incorporating Multidisciplinary Teams ...

In a previous single center trial, the use of the SAMURAI PICU bundle improved early identification of high-risk patients, increased shared ...

2.

withpower.com

withpower.com/trial/samurai-program-for-reducing-cardiac-arrests-in-pediatric-icu-ff7e3

SAMURAI Program for Reducing Cardiac Arrests in ...

A study on quality improvement in pediatric cardiac intensive care units showed that proactive programs can help reduce cardiac arrests in children with heart ...

3.

kindervelt.org

kindervelt.org/advancing-pediatric-critical-care-the-picu-innovation-accelerator-at-cincinnati-childrens/

The PICU Innovation Accelerator at Cincinnati Children's

Ultimately, we aspire to diminish cardiac arrests and enhance outcomes for critically ill children in the five participating hospitals, mirroring the success ...

4.

cincinnatichildrens.org

cincinnatichildrens.org/professional/subspecialist-news/heart/cardiac-arrest-reduction

Preventing Cardiac Arrest in Pediatric CICUs

Use of the bundle reduced IHCA occurrence by 30%, exceeding a targeted 25% reduction. Results were published in JAMA Pediatrics in July 2022. “We collaborated ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8738107/

Assessment of a Situation Awareness Quality Improvement ...

To utilize improved situation awareness to decrease cardiopulmonary resuscitation (CPR) events by 25% over 18-months and demonstrate process and outcome ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26289236/

Effect of a Real-Time Pediatric ICU Safety Bundle ...

A real-time visual display showed data on presence of consent for treatment, restraint orders, presence of urinary catheters, deep venous thrombosis (DVT) ...

7.

sccm.org

sccm.org/blog/critically-ill-children-and-the-icu-liberation-bundle

Critically Ill Children and the ICU Liberation Bundle

This is the first multicenter report of the impact of the ICU Liberation Bundle on clinical outcomes in critically ill children.