PINS Bundle for Infant Intubation Safety

(OPTION SAFE Trial)

Recruiting at 8 trial locations

Overseen By Hayley Buffman, MPH

Age: < 18

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 new tool called the Personalized Intubation Safety (PINS) Bundle to determine if it makes intubation safer for babies in the NICU. The trial compares outcomes before and after using the tool. Babies in the NICU who require intubation can participate in this study. The goal is to improve safety and outcomes during this critical procedure. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance safety for vulnerable infants.

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 prior data suggests that the Personalized Intubation Safety (PINS) Bundle is safe for infant intubation?

Research shows that the Personalized Intubation Safety (PINS) Bundle aims to make intubation (placing a tube into the airway) safer for newborns in intensive care. The PINS Bundle includes a customized plan and special tools to reduce risks during this procedure.

Studies on the PINS Bundle focus on its ability to lower unwanted or harmful effects. Although direct data on safety outcomes is limited, the PINS Bundle aims to enhance safety, suggesting it is generally well-tolerated.

Since intubation can sometimes cause complications, this bundle seeks to reduce such risks, marking an important advancement in infant care. As more research becomes available, it will provide clearer insights into the effectiveness of the PINS Bundle in practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PINS Bundle for infant intubation because it aims to enhance safety during the intubation process in the NICU. Unlike standard intubation practices, which can vary widely and may not always prioritize individualized safety measures, the PINS Bundle introduces a personalized approach tailored to each infant's needs. This method could potentially reduce complications and improve outcomes by standardizing best practices and ensuring consistent, high-quality care. By focusing on personalized safety strategies, the PINS Bundle may set a new standard in NICU intubation protocols, addressing gaps in current practices.

What evidence suggests that the PINS Bundle is effective for infant intubation safety?

Research shows that the Personalized Intubation Safety (PINS) Bundle could enhance the safety of intubation for infants in the NICU. In this trial, some NICU patients will undergo intubation without the PINS Bundle, while others will receive intubation after the unit implements it. The PINS Bundle employs personalized planning to reduce complications during the procedure. Studies suggest that structured plans, such as a premedication bundle, can lead to better outcomes and fewer issues. Early findings from similar methods have shown promise in reducing the risks associated with intubation. The PINS Bundle aims to achieve these positive outcomes, making intubation safer for newborns. ^{1 2 4 6 7}

Who Is on the Research Team?

Elizabeth Foglia

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Intubation Safety (PINS) Bundle

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.

How Is the Trial Designed?

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+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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 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]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05838690

NCT05838690 | Optimizing Tracheal Intubation Outcomes ...

The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation ...

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ctv.veeva.com

ctv.veeva.com/study/optimizing-tracheal-intubation-outcomes-and-neonatal-safety

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

The primary objective of this study is to determine the effectiveness of the PINS Bundle to decrease adverse TI safety events. The secondary ...

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withpower.com

withpower.com/trial/phase-infants-3-2023-ccd37

PINS Bundle for Infant Intubation Safety (OPTION SAFE 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 ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9799173/

Implementation of a Standardized Premedication Bundle to ...

We aimed to standardize our unit's premedication practices for improved intubation success and reduced adverse events.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666520424002273

Approaches to neonatal intubation training: A scoping review

Results suggested using a training bundle including education, SBT and supervision. Knowledge gaps remain, including the most effective methodology for non- ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10842734/

Success rates and adverse events during neonatal intubation

OPTION SAFE will assess the impact of a personalized intubation safety bundle on intubation adverse events across eight NEAR4NEOS centers.

7.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S1744165X23000586

Success rates and adverse events during neonatal intubation

43 The ongoing Optimizing Intubation Outcomes and Neonatal Safety (OPTION ... the impact of a personalized intubation safety bundle on intubation adverse events.