SBIR/STTR Award attributes
Project Summary/Abstract Minnesota HealthSolutions Corporation and Children’s Hospital Los Angeles propose to develop a novel pediatric/neonatal endotracheal tube securement system with the aim of reducing unplanned extubation and associated complication rates. Mechanical ventilation through an endotracheal tube is routine in pediatric and neonatal intensive care units and has contributed to improved survival and reduced morbidity. However, unplanned extubations are unfortunately common, and are associated with hemodynamic instability, hypoxia, hypercarbia, airway trauma, ventilator associated pneumonia, intraventricular hemorrhage, and death. Neonates, infants and children have unique challenges with endotracheal tube securement and pediatric patients are at particularly high risk for unplanned extubation due to anatomic and physiologic factors. There exists great enthusiasm for improved devices or methods for safely maintaining pediatric endotracheal tubes. The proposed project explores a novel securement system with several innovative features. The objective of this proposed fast-track project is to develop and evaluate a neonatal/pediatric securement system that leverages a novel interlocking stabilizer concept which is used in an FDA cleared adult endotracheal tube securement system. While building off the adult system, key elements of innovation unique to the pediatric system include an adjustable stabilizer design where the interlocking securement mechanism is locked directly onto any FDA approved ET tube and adjustably fits into a corresponding ribbed receiver on a stabilizer with an easy-to-use locking system. The innovative stabilizer is integrated into comfortable, non-skin-irritating retention structures specifically designed to fit pediatric patients, including pre-term neonates. Several initial pediatric prototypes have undergone extensive, iterative feedback from over 25 respiratory therapists, neonatologists, and intensive care physicians and nurses. This has resulted in mature designs of three securement devices to span the range from preterm neonates to children. The objective of phase I is to finalize the design and manufacture the 3 different sized pediatric prototypes and evaluate their: 1) feedback to inform design, workflow and usability refinements in focus groups and 2) ability to resist pull events in a bench-top model. The objective of phase II is to advance the prototype design to a finished production product, conduct performance bench testing to demonstrate safety and efficacy, and evaluate manufactured units in a phase II randomized controlled trial.Project Narrative Unplanned extubation (the unintentional removal of a patient’s life sustaining breathing tube) is common in mechanically ventilated patients in the NICU (Average = 18.2%; Range 1.0% - 80.8%) and the PICU (Average 8%; Range 0.8% - 18.5%).15 Unplanned extubation is potentially devastating and costly, often leading to a variety of serious, life-threatening cardiovascular and respiratory complications, increased hospital length of stay (16.5 days vs 10 days), increased attributable hospital cost per event by $36,000, and is the fourth most common adverse event in NICUs in the United States. An improved pediatric securement system that reduces the rate of unplanned extubation is needed and would improve outcomes for neonates, infants and children.
