PINS Bundle for Infant Intubation Safety
(OPTION SAFE Trial)
Recruiting in Palo Alto (17 mi)
+7 other locations
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.
12345Is 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.
12567What 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.
12578Eligibility 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
Participant Groups
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
Find a Clinic Near You
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
More Trial Locations
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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
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.
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.
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.
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.
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).
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).