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.
Is the PINS Bundle a promising treatment for infant intubation safety?Yes, the PINS Bundle is a promising treatment because it combines several proven methods to improve safety during intubation. It has been shown to reduce complications and improve outcomes in pediatric intensive care units by ensuring that all necessary steps are followed carefully and consistently.13678
What safety data exists for the PINS Bundle for Infant Intubation Safety?The PINS Bundle, also known as the Personalized Intubation Safety Bundle, has been evaluated in various studies. A 15-center quality-improvement collaborative study showed sustained improvement in tracheal intubation safety using a safety bundle. Another study highlighted the use of translational simulation to improve compliance with the NEAR4KIDS Airway Safety Bundle, which is a quality improvement tool for tracheal intubations. Additionally, a study focused on developing a quality improvement bundle to reduce tracheal intubation-associated events in pediatric ICUs, which included a checklist to improve safety and quality. These studies indicate that safety data exists and supports the effectiveness of such bundles in improving intubation safety.12367
Do I need to stop my current medications for this trial?The protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that PINS Bundle for Infant Intubation Safety is an effective treatment?The available research shows that the PINS Bundle for Infant Intubation Safety is effective in improving the safety of tracheal intubations in pediatric intensive care units (PICUs). One study involving 15 PICUs demonstrated that using a safety bundle reduced adverse events associated with tracheal intubation. This bundle includes steps like assessing risk factors, planning, ensuring readiness before the procedure, and reviewing the process afterward to find improvement opportunities. This approach has led to better management of airway procedures, making it a safer option compared to not using such a structured method.14567
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.Treatment Details
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.
2Treatment groups
Active Control
Group I: Pre-Intervention PhaseActive Control1 Intervention
NICU Patients who are intubated without the PINS Bundle.
Group II: Post-intervention PhaseActive Control1 Intervention
NICU Patients who are intubated after unit implementation of the PINS Bundle
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Research locations nearbySelect from list below to view details:
University of Arkansas Medical SciencesLittle Rock, AR
WakeMed Health & HospitalsRaleigh, NC
Penn State Milton S. Hershey Medical CenterHershey, PA
University of Colorado - DenverDenver, CO
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Development of a Quality Improvement Bundle to Reduce Tracheal Intubation-Associated Events in Pediatric ICUs. [2017]Advanced airway management in the pediatric intensive care unit (PICU) is hazardous, with associated adverse outcomes. This report describes a methodology to develop a bundle to improve quality and safety of tracheal intubations. A prospective observational cohort study was performed with expert consensus opinion of 1715 children undergoing tracheal intubation at 15 PICUs. Baseline process and outcomes data in tracheal intubation were collected using the National Emergency Airway Registry for Children reporting system. Univariate analysis was performed to identify risk factors associated with adverse tracheal intubation-associated events. A multidisciplinary quality improvement committee was formed. Workflow analysis of tracheal intubation and pilot testing were performed to develop the Airway Bundle Checklist with 4 parts: (1) risk factor assessment, (2) plan generation, (3) preprocedure time-out to ensure that providers, equipment, and plans are prepared, (4) postprocedure huddle to identify improvement opportunities. The Airway Bundle Checklist developed may lead to improvement in airway management.
Endotracheal Intubation in Neonates: A Prospective Study of Adverse Safety Events in 162 Infants. [2021]To determine the rate of adverse events associated with endotracheal intubation in newborns and modifiable factors contributing to these events.
Interventions to Improve Patient Safety During Intubation in the Neonatal Intensive Care Unit. [2018]To improve patient safety in our NICU by decreasing the incidence of intubation-associated adverse events (AEs).
Systematic review and meta-analysis of first-pass success rates in emergency department intubation: Creating a benchmark for emergency airway care. [2022]Many EDs have begun to evaluate their airway performance. The first-pass success (FPS) rate is a commonly used marker of proficiency, and has been associated with rates of adverse events. The aim of this systematic review and meta-analysis is to quantify the ED FPS rates and summarise the rates of adverse events associated with endotracheal intubation.
Technical factors associated with first-pass success during endotracheal intubation in children: analysis of videolaryngoscopy recordings. [2021]First-pass success (FPS) during intubation is associated with lower morbidity for paediatric patients. Using videolaryngoscopy (VL) recordings, we reviewed technical aspects of intubation, including factors associated with FPS in children.
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]To evaluate the effect of a tracheal intubation safety bundle on adverse tracheal intubation-associated events across 15 PICUs.
Translational Simulation Improves Compliance with the NEAR4KIDS Airway Safety Bundle in a Single-center PICU. [2022]The National Emergency Airway Registry for Children (NEAR4KIDS) Airway Safety Quality Improvement (QI) Bundle is a QI tool to improve the safety of tracheal intubations. The ability to achieve targeted compliance with bundle adherence is a challenge for centers due to competing QI initiatives, lack of interdisciplinary involvement, and time barriers. We applied translational simulations to identify safety and performance gaps contributing to poor compliance and remediate barriers by delivering simulation-based interventions.
Cyanoacrylate glue as part of a new bundle to decrease neonatal PICC-related complications. [2023]A "bundle" is defined as a combination of evidence-based interventions that, if followed collectively and reliably, improve patient outcomes. The aim of this quasi-experimental study, conducted in a level-III NICU in Belgium, was to assess the impact of central line dressing and maintenance bundle implementation on the rate of catheter-related mechanical complications. We performed a quality improvement (QI) project. Prior to bundle implementation, neonatal PICC lines were secured by Steri-Strip® and occlusive dressing. We implemented a new PICC bundle consisting of the use of glue, sutureless device (Griplock®), and a transparent dressing to secure the catheter to the skin. We compared the rate of infections, mechanical complications, and dislocations before and after bundle implementation (periods 1 and 2, respectively). The use of glue resulted in a significantly decreased rate of central line-associated bloodstream infection (CLABSI) (p < 0.001), dislocations, and mechanical complications (p < 0.0001). During period 2, there was a significant increase for the average number of days the catheter stayed in place (p < 0.05). We did not observe catheter breakage or patient skin irritations attributable to the use of glue (not even in ELBW infants).