SAMURAI Program for Reducing Cardiac Arrests in Pediatric ICU

(SAMURAI PICU Trial)

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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pragmatic prospective Type 1 Hybrid Implementation-Effectiveness Trial study is to learn if The Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In (SAMURAI) the PICU Bundle can reduce PICU CPR events. The SAMURAI PICU Bundle includes an automated PICU warning tool, twice daily huddles and mitigation plans. The main questions it aims to answer are: Is the adapted bundle will be acceptable, feasible, and appropriate to stakeholders prior to implementation? Will there be at least a 30% relative reduction in PICU CPR events following successful implementation of the bundle? Each site will: Adapt and implement SAMURAI PICU Bundle which includes an automated PICU warning tool, twice daily huddles and mitigation plans

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 data supports the effectiveness of the SAMURAI PICU Bundle treatment for reducing cardiac arrests in pediatric ICU?

A study on quality improvement in pediatric cardiac intensive care units showed that proactive programs can help reduce cardiac arrests in children with heart conditions, suggesting that similar approaches like the SAMURAI PICU Bundle might be effective. ^{1 2 3 4 5}

Is the SAMURAI Program for Reducing Cardiac Arrests in Pediatric ICU safe for children?

The available research does not provide specific safety data for the SAMURAI Program or SAMURAI PICU Bundle, but general safety measures in pediatric intensive care units, like standardized checklists, have been shown to reduce medical errors and improve safety. ^{6 7 8 9 10}

How does the SAMURAI PICU Bundle treatment differ from other treatments for reducing cardiac arrests in pediatric ICU?

The SAMURAI PICU Bundle is unique because it likely involves a combination of interventions specifically designed to prevent cardiac arrests in critically ill children, rather than focusing on a single drug or treatment. This approach may include system factors and modifiable interventions that are tailored to the pediatric intensive care setting, which is different from standard treatments that might not address these specific needs. ^{3 4 7 11 12}

Research Team

Maya L Dewan, MD, MPH

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Shifting the Paradigm: A Quality Improvement Approach to Proactive Cardiac Arrest Reduction in the Pediatric Cardiac Intensive Care Unit. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Epidemiology of Cardiopulmonary Arrest and Outcome of Resuscitation in PICU Across China: A Prospective Multicenter Cohort Study. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Epidemiology and outcomes of in-hospital cardiac arrest in critically ill children across hospitals of varied center volume: a multi-center analysis. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Impact of System Factors and Modifiable ICU Interventions on the Outcome of Cardio-pulmonary Resuscitation in PICU. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

Comparison of Two Different Intensive Care Unit Systems for Severely Ill Children in Japan: Data from the JaRPAC Registry. [2021]

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

Prevalence of adverse events in pediatric intensive care units in the United States. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Care bundles to reduce unplanned extubation in critically ill children: a systematic review, critical appraisal and meta-analysis. [2022]

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

Adverse Events in Pediatric Inpatients: The Japan Adverse Event Study. [2023]

9. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Causes, timing, and modes of death in a tertiary pediatric intensive care unit: Five years' experience. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Implementing Rounding Checklists in a Pediatric Oncologic Intensive Care Unit. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Epidemiology of Cardiopulmonary Resuscitation in Critically Ill Children Admitted to Pediatric Intensive Care Units Across England: A Multicenter Retrospective Cohort Study. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Factors and Neurologic Outcomes Associated With Resuscitation in the Pediatric Intensive Care Unit. [2022]