Smart Checklist for Pediatric Endotracheal Intubation

(SMART PICU Trial)

Recruiting at 5 trial locations

Overseen By Hayley Buffman, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Endotracheal tube exchanges

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

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a Smart Checklist to help medical teams perform safer intubations (placing a tube to help someone breathe) in children in intensive care. The aim is to determine if using this checklist can reduce complications during the procedure. It compares patients treated with and without the checklist in six different pediatric ICUs. If a child is in a pediatric ICU and requires intubation, they might be eligible for this trial. As an unphased trial, this study offers a unique opportunity to contribute to improving safety in pediatric intensive care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Smart Checklist is safe for pediatric endotracheal intubation?

Research has shown that the Smart Checklist enhances the safety of intubations (placing a tube into the windpipe) in children's intensive care units. A study involving 1,715 children across 15 units identified the risks associated with this procedure, leading to the development of the Smart Checklist to improve safety.

The checklist aims to reduce complications when securing a child's airway. It guides healthcare teams through crucial steps during intubation, preventing mistakes and enhancing care.

As a tool rather than a medication, the Smart Checklist's safety concerns focus on its effectiveness in guiding doctors through the correct steps, rather than drug-like side effects. Studies have demonstrated that using the checklist can make intubations safer, reducing risks for young patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Checklist for pediatric endotracheal intubation because it offers a systematic approach to improve safety and efficiency during a critical procedure in the pediatric intensive care unit (PICU). Unlike traditional methods that rely heavily on the clinician's memory and experience, the Smart Checklist provides a structured guide that can reduce errors and enhance team communication. This method has the potential to standardize the intubation process, leading to better outcomes for young patients.

What evidence suggests that the Smart Checklist is effective for reducing Adverse Airway Outcomes?

Research shows that using checklists during medical procedures, such as inserting a breathing tube, can greatly improve patient safety and outcomes. Studies have shown that checklists help reduce mistakes and ensure all necessary steps are followed. Dr. Akira Nishisaki developed processes that make managing children's airways safer. This trial tests the Smart Checklist for its effectiveness. Designed to be personalized and flexible, it tailors to the specific needs of each situation. Early findings suggest that this approach can lead to better safety and fewer complications when inserting breathing tubes in children's intensive care units. Participants in the post-intervention phase of this trial will be intubated using the Smart Checklist, while those in the pre-intervention phase will not use the checklist. ^{1 3 6 7 8}

Who Is on the Research Team?

Akira Nishisaki, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for all patients who are undergoing endotracheal intubation in the pediatric intensive care unit (PICU) at participating hospitals. It does not include those having an endotracheal tube exchange, as that's considered a different procedure.

Inclusion Criteria

All patients intubated in the pediatric intensive care unit (PICU) at participating sites are eligible.

Exclusion Criteria

I have had a procedure to change my breathing tube.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Phase

PICU patients are intubated without the Smart Checklist

Duration of ICU stay, up to 180 days

Post-Intervention Phase

PICU patients are intubated with the Smart Checklist implemented

Duration of ICU stay, up to 180 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

During the ICU stay, up to 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Smart Checklist

Trial Overview The study is testing a digital 'Smart Checklist' designed to help healthcare teams during intubations in the PICU. The goal is to see if this checklist can reduce complications by using tailored prompts from electronic health records.

How Is the Trial Designed?

Group I: Pre-Intervention Phase Active Control 1 Intervention

PICU patients who are intubated without the Smart checklist

Group II: Post-Intervention Phase Active Control 1 Intervention

PICU patients who are intubated after implementation of the Smart checklist in the pediatric intensive care unit.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The Neonatal Intubation Checklist significantly improved the proficiency of neonatal intubation among transport teams, with proficiency scores increasing from 29 to 57 after using the checklist (P < .001).

Using the checklist also reduced the time to perform intubation from an average of 626 seconds to 479 seconds, demonstrating that safety and efficiency can be enhanced without prolonging the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Testing of a Neonatal Intubation Checklist for an Air Medical Transport Team. Davidson, LA., Utarnachitt, RB., Mason, A., et al.[2019]

A newly developed checklist for pediatric trauma resuscitation, created by a focus group of trauma specialists, significantly improved adherence to the Advanced Trauma Life Support (ATLS) protocol during simulated resuscitations, with an average performance score increase of 4.9 points (P < 0.001).

The use of the checklist did not increase the perceived workload of the trauma team members, indicating that it can enhance performance without adding stress during critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving ATLS performance in simulated pediatric trauma resuscitation using a checklist. Parsons, SE., Carter, EA., Waterhouse, LJ., et al.[2014]

A study involving 1715 children across 15 pediatric intensive care units (PICUs) identified risks associated with tracheal intubation and developed an Airway Bundle Checklist to enhance safety and quality during the procedure.

The checklist includes key components such as risk factor assessment, planning, a pre-procedure time-out, and a post-procedure huddle, which may help reduce adverse outcomes in pediatric airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Quality Improvement Bundle to Reduce Tracheal Intubation-Associated Events in Pediatric ICUs. Li, S., Rehder, KJ., Giuliano, JS., et al.[2017]

The use of a novel peri-intubation checklist significantly reduced the rate of omitted tasks during simulated airway management scenarios, with a decrease from 45.7% in the control group to 13.5% in the checklist group, representing a 32.2% absolute difference.

While the checklist improved task completion, it also resulted in longer times to definitive airway management in the first two scenarios, indicating a trade-off between thoroughness and speed in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does utilization of an intubation safety checklist reduce omissions during simulated resuscitation scenarios: a multi-center randomized controlled trial. Forristal, C., Hayman, K., Smith, N., et al.[2021]

A systematic review of 11 studies involving 3261 patients found that using airway checklists during endotracheal intubation did not significantly reduce mortality rates, indicating that checklists may not improve overall survival in critically ill patients.

However, checklist use was associated with a reduction in hypoxic events during intubation, suggesting that while they may not lower mortality, they could help prevent some complications related to oxygen deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. Turner, JS., Bucca, AW., Propst, SL., et al.[2021]

The implementation of the pedSOAP-M checklist in pediatric anesthesia effectively detected relevant errors in 10.8% of cases, highlighting its importance in preventing potentially harmful incidents during surgery.

Errors related to pharmaceuticals, particularly incorrect patient weight entries, were the most common, and the presence of experienced anesthetists significantly improved error detection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of errors detected by a short team briefing in pediatric anesthesia. Keil, O., Brunsmann, K., Boethig, D., et al.[2022]

This systematic review aims to evaluate the effectiveness of using checklists during multidisciplinary rounds in pediatric intensive care units, focusing on their impact on mortality and patient safety outcomes.

The review will include various studies involving pediatric patients under 18 years old and will compare outcomes between rounds with and without checklists, potentially providing valuable insights into improving communication and adherence to best practices in critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of checklists in multidisciplinary rounds for improving patient safety in the pediatric intensive care unit: a systematic review protocol. Dos Santos Alves, DF., da Silva, SO., Ullman, A., et al.[2022]

The use of a safe surgery checklist (CL) led to a slight reduction in adverse events (AEs) from 13.6% to 11.8%), but this change was not statistically significant, indicating that the checklist alone may not be sufficient to reduce AEs.

However, there was a significant reduction in patient deaths (p=0.007) associated with the use of the checklist, suggesting that while the checklist did not significantly lower AEs, it may contribute to improved patient outcomes when combined with other safety strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the Surgical Safety Checklist on the incidence of adverse events: contributions from a national study. Faria, LR., Moreira, TR., Carbogim, FDC., et al.[2023]

A multidisciplinary panel of 14 experts developed a consensus on a 17-item checklist for paediatric tracheal intubation in the emergency department, enhancing patient safety during airway management.

The checklist includes essential components across five categories: patient assessment, preparation, pharmacy, equipment, and personnel, ensuring a comprehensive approach to managing paediatric airway procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a paediatric airway management checklist for the emergency department: a modified Delphi approach. Miller, KA., Prieto, MM., Wing, R., et al.[2023]

Checklists are essential tools in healthcare that enhance patient safety by ensuring that all necessary steps in procedures are followed, promoting teamwork, and standardizing care across various settings, including pediatrics.

Successful implementation of checklists in pediatric care requires strong leadership and training to overcome barriers such as staff attitudes, cultural challenges, and work overload, ensuring that the checklists are effectively utilized to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The checklists: A help or a hassle?] Concha-Torre, A., Díaz Alonso, Y., Álvarez Blanco, S., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-intubation-complication-9-2023-41da1

Smart Checklist for Pediatric Endotracheal Intubation Research shows that using checklists in medical procedures, like endotracheal intubation, can improve patient safety and outcomes. For example, a study ...

2. ahrq.gov ahrq.gov/news/newsletters/e-newsletter/961.html

Researcher Akira Nishisaki Designs Quality Improvement ... Dr. Nishisaki has designed and implemented easily modifiable quality improvement processes that make pediatric airway management safer during tracheal ...

3. reporter.nih.gov reporter.nih.gov/search/kUT5X1FdwEy1THilMXTlxg/project-details/10736244

Project Details We will transform the safety of pediatric tracheal intubation at 6 Pediatric ICUs by implementing a digitized Smart Checklist that has three specific features: ...

4. highergov.com highergov.com/grant/R01HS029188/

Grant R01HS029188 The Children's Hospital Of Philadelphia Smart Checklist Implementation for Pediatric Tracheal Intubations in the ICU - Multicenter Study: Smart PICU - Project Summary

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06085326/smart-checklist-implementation-for-pediatric-tracheal-intubations-in-the-icu-multicenter-study?state=OH&city=Akron

Smart Checklist Implementation for Pediatric Tracheal ... The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on ...

6. trialx.com trialx.com/clinical-trials/listings/274466/smart-checklist-implementation-for-pediatric-tracheal-intubations-in-the-icu-multicenter-study/?&radius=50

Smart Checklist Implementation for Pediatric Tracheal ... The primary objective of this study is to determine the clinical impact of the personalized, dynamic, adaptive Smart Checklist implementation on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6822618/

Process Conformance is Associated with Successful First ... Intubation is an essential, life-saving skill but associated with a high risk for adverse outcomes. Intubation protocols have been implemented to increase ...

8. clinconnect.io clinconnect.io/trials/NCT06085326

Smart Checklist Implementation for Pediatric Tracheal The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality ...