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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to implement a patient-provider dyad tailored, Electronic Health Record (EHR)-informed, digitized Smart Checklist as a Quality Improvement (QI) intervention to support bedside clinician teams to reduce Adverse Airway Outcomes (AAO) across 6 diverse pediatric intensive care units (ICUs).

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 data supports the effectiveness of the treatment 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 developed a checklist for pediatric airway management that may enhance safety during intubation by ensuring all necessary steps are followed. ^{1 2 3 4 5}

Is the Smart Checklist for Pediatric Endotracheal Intubation safe for use in humans?

Checklists, like the Smart Checklist, are generally considered safe and are used to improve patient safety by ensuring all necessary steps are followed during medical procedures. They help reduce errors and improve communication among medical staff, which can lead to safer outcomes for patients. ^{4 6 7 8 9}

How is the Smart Checklist for Pediatric Endotracheal Intubation different from other treatments for pediatric intubation?

The Smart Checklist for Pediatric Endotracheal Intubation is unique because it provides a structured approach to ensure all necessary steps are followed during the procedure, improving safety and efficiency. Unlike other treatments, it focuses on standardizing care and reducing errors through a systematic checklist, which is not a common feature in traditional intubation methods. ^{1 3 4 6 10}

Research Team

Akira Nishisaki, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Improving ATLS performance in simulated pediatric trauma resuscitation using a checklist. [2014]

2. United States 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a Quality Improvement Bundle to Reduce Tracheal Intubation-Associated Events in Pediatric ICUs. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Development of a paediatric airway management checklist for the emergency department: a modified Delphi approach. [2023]

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

Association of Checklist Use in Endotracheal Intubation With Clinically Important Outcomes: A Systematic Review and Meta-analysis. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

[The checklists: A help or a hassle?] [2021]

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

Does utilization of an intubation safety checklist reduce omissions during simulated resuscitation scenarios: a multi-center randomized controlled trial. [2021]

8. Brazil pubmed.ncbi.nlm.nih.gov

Effect of the Surgical Safety Checklist on the incidence of adverse events: contributions from a national study. [2023]

9. France pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of errors detected by a short team briefing in pediatric anesthesia. [2022]

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

Development and Testing of a Neonatal Intubation Checklist for an Air Medical Transport Team. [2019]