Bougie-Integrated Endotracheal Intubation Stylet

It is well established that difficulty and multiple attempts at endotracheal intubation (ETI) during emergency circumstances result in up to a 4-fold increase in complications, including cardiac arrest. In the tactical combat casualty care (TCCC) environment, ETI encompasses the majority of combat prehospital airway securement. Unfortunately, ETI is one of the most common incorrectly performed life-saving interventions in this setting, with failure rates as high as 18% by paramedics, and much higher rates of failed first-pass success. Error rates in the civilian sector are similar, where prehospital paramedic first-pass success ranges between 46% – 77%. One review noted that almost one in four patients receiving prehospital ETI were exposed to an error. Struggling with ETI leads to higher morbidity and increased downstream patient illness. Although operator skill, patient issues, and environmental factors all contribute to ETI challenges, there also exists a large technology gap that prevents patients from accessing safe and certain ETI in all circumstances and conditions. This is especially the case for less experienced operators whose incumbent responsibilities include this life-saving procedure. In the context of TCCC, this gap will be exacerbated within the long-distance en-route care or prolonged field care scenarios anticipated in the multi-domain operations environment. In these scenarios smaller, dispersed mobility forces will be more likely to perform definitive airway management (ETI) on casualties due to constraints imposed by prolonged evacuation and transit times. Highly experienced operators may not be immediately available, and limited resources will exacerbate strains associated with ETI-related complications. Operator visualization of the vocal cords has historically been the most difficult step for operators while performing ETI. However, despite the introduction of video-assisted laryngoscopy into practice almost 20 years ago, which arguably provides enhanced visualization, gaps remain in ETI success. This is because VL, while making visualization easier, has made the subsequent steps of insertion of the endotracheal tube (ETT) through the vocal cords and cannulation of the ETT into the trachea more difficult, resulting in a statistical inversion of the historical pain points. During our Phase I effort we demonstrated the technical feasibility of developing and manufacturing our bougie-integrated stylet technology. Our technology is founded upon a modern understanding of the anatomic and skill issues that inhibit rapid ETI success, particularly during video laryngoscopy. Our device uses a novel integrated bougie, which can be directed down the trachea via a memory wire, thus enabling easier vocal cords insertion and an unimpeded pathway for the ETT. Our aim is to finalize our technology which also aims to complement traditional direct laryngoscopy (DL) ETI, thus enhancing all current ETI enabling technologies.