PINS Bundle for Infant Intubation Safety

(OPTION SAFE Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Elizabeth Foglia

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Endotracheal tube exchanges

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if the PINS Bundle can make intubation safer for newborns in intensive care. The PINS Bundle involves personalized planning and using specific tools and techniques to reduce complications during intubation.

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

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

What data supports the effectiveness of the PINS Bundle treatment for infant intubation safety?

Research shows that using a safety bundle for tracheal intubation in pediatric intensive care units can reduce adverse events and improve safety. This approach involves careful planning, preparation, and review, which has been shown to enhance the quality and safety of intubations. ^{1 2 3 4 5}

Is the PINS Bundle for Infant Intubation generally safe for humans?

The PINS Bundle, also known as the Airway Safety Bundle, has been studied in various settings to improve the safety of tracheal intubations (placing a tube into the windpipe) in infants and children. Research shows that using this bundle can reduce adverse events (unwanted side effects) during intubation, suggesting it is generally safe when used properly. ^{1 2 5 6 7}

What makes the PINS Bundle treatment unique for infant intubation safety?

The PINS Bundle is unique because it combines multiple evidence-based interventions into a structured checklist to improve the safety and quality of tracheal intubations in infants. It includes steps like risk assessment, planning, pre-procedure checks, and post-procedure reviews, which are designed to reduce adverse events during intubation. ^{1 2 5 7 8}

Research Team

Elizabeth Foglia

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for infants who need a tracheal intubation procedure in the neonatal intensive care unit (NICU). It's not specified what conditions exclude an infant from participating, but typically those with certain health issues may not be eligible.

Inclusion Criteria

My infant needs a breathing tube in the NICU.

Exclusion Criteria

I have had an endotracheal tube exchange.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Phase

NICU patients are intubated without the PINS Bundle

Duration not specified

Post-Intervention Phase

NICU patients are intubated after unit implementation of the PINS Bundle

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days

Treatment Details

Interventions

• Personalized Intubation Safety (PINS) Bundle (Behavioural Intervention)

Trial Overview The study is testing the Personalized INtubation Safety (PINS) Bundle, which is a planning tool designed to improve the safety and outcomes of intubation procedures in newborns within NICUs.

Participant Groups

Group I: Pre-Intervention Phase Active Control 1 Intervention

NICU Patients who are intubated without the PINS Bundle.

Group II: Post-intervention Phase Active Control 1 Intervention

NICU Patients who are intubated after unit implementation of the PINS Bundle

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Findings from Research

The implementation of a tracheal intubation safety bundle across 15 pediatric intensive care units (PICUs) led to a significant reduction in adverse tracheal intubation-associated events, with a decrease from 17.5% at baseline to 13.7% after 24 months of sustained adherence.

The safety bundle, which included performance reporting and airway safety checklists, was associated with a sustained decrease in adverse events, demonstrating its effectiveness as a quality-improvement intervention in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Improvement in Tracheal Intubation Safety Across a 15-Center Quality-Improvement Collaborative: An Interventional Study From the National Emergency Airway Registry for Children Investigators. Nishisaki, A., Lee, A., Li, S., et al.[2021]

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 systematic review and meta-analysis of 42,081 intubations across 83 institutions revealed a first-pass success (FPS) rate of 84.1% in emergency departments, indicating a high level of proficiency in airway management.

Common adverse events associated with endotracheal intubation included hypoxia (6.4%), hypotension (3.0%), and oesophageal intubation (3.5%), highlighting the importance of monitoring for these complications during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. Park, L., Zeng, I., Brainard, A.[2022]

In a study of 237 pediatric intubation attempts using video-assisted laryngoscopy, 73% of first attempts were successful, highlighting the effectiveness of this technique in reducing morbidity during intubation.

Factors such as placing the blade tip into the vallecula and achieving a clear glottic view significantly increased the chances of first-pass success, with optimal positioning of the glottic opening on the video screen further enhancing success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical factors associated with first-pass success during endotracheal intubation in children: analysis of videolaryngoscopy recordings. Miller, KA., Monuteaux, MC., Nagler, J.[2021]

The implementation of translational simulations significantly improved compliance with the NEAR4KIDS Airway Safety Quality Improvement Bundle from 66% to 93.7% and increased the use of apneic oxygenation from 27.9% to 77.9% over a 9-month period following the intervention.

Despite the improvements in compliance and practice, there was no change in the occurrence of adverse tracheal intubation-associated events, indicating that while adherence to safety protocols improved, patient safety outcomes remained stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational Simulation Improves Compliance with the NEAR4KIDS Airway Safety Bundle in a Single-center PICU. Colman, N., Newman, JW., Nishisaki, A., et al.[2022]

In a study of 304 intubations in 178 newborns, adverse events occurred in 39% of cases, highlighting a significant risk associated with this procedure in neonatal intensive care units.

The likelihood of experiencing adverse events increased with the number of intubation attempts and was particularly high during emergent intubations, suggesting that strategies to reduce attempts and manage emergencies could enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants. Hatch, LD., Grubb, PH., Lea, AS., et al.[2021]

The implementation of a standardized checklist for intubation in the NICU led to a significant reduction in intubation-associated adverse events (AEs), decreasing from 46% to 36% of intubations, indicating improved patient safety.

Specifically, the incidence of bradycardia dropped from 24.2% to 9.3% and hypoxemia from 44.3% to 33.1%, demonstrating that the checklist and other interventions effectively minimized critical complications during intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit. Hatch, LD., Grubb, PH., Lea, AS., et al.[2018]

The implementation of a new bundle for securing neonatal PICC lines, which included the use of glue and a sutureless device, significantly reduced the rates of central line-associated bloodstream infections (CLABSI) and mechanical complications in a NICU setting, based on a quasi-experimental study conducted in Belgium.

No glue-related complications were observed, even in extremely low birth weight infants, indicating that this method is both safe and effective for improving catheter securement and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyanoacrylate glue as part of a new bundle to decrease neonatal PICC-related complications. Piersigilli, F., Iacona, G., Yazami, S., et al.[2023]

References

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

Sustained Improvement in Tracheal Intubation Safety Across a 15-Center Quality-Improvement Collaborative: An Interventional Study From the National Emergency Airway Registry for Children Investigators. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Australia pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. [2022]

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

Technical factors associated with first-pass success during endotracheal intubation in children: analysis of videolaryngoscopy recordings. [2021]

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

Translational Simulation Improves Compliance with the NEAR4KIDS Airway Safety Bundle in a Single-center PICU. [2022]

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

Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants. [2021]

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

Interventions to Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Cyanoacrylate glue as part of a new bundle to decrease neonatal PICC-related complications. [2023]