AssuranceET: a novel endotracheal tube sealing mechanism to protect pediatric patients from airway trauma and collapse while empowering clinician decision-making.

Abstract Every year in the United States, tens of thousands of children are placed on mechanical ventilation, of which an estimated 1 in 5 are at risk of serious complications. Complications in these environments commonly arise from airway trauma, inadequate oxygenation, and aspiration leading to infection. At the root of many of these complication risks come from the device that connects the patient to the ventilator – an endotracheal tube (ETT). For decades, ETTs have used an inflatable balloon to create a seal in the airway to seal the airway and prevent aspiration and enable ventilation. The problem is that these balloons are failure points for patients and providers. The balloons often crease leading to increased aspiration risk, or can be easily overinflated, leading to increased risk of trauma and collapse. Additionally, most ETTs in pediatrics were not originally designed with balloons in mind, as they were historically uncuffed. In this transition, there remains a high uncertainty that today’s tools adequately help tomorrow’s children. To solve this problem, Respair developed AssuranceET, a pediatric first ETT that replaces the error-prone balloon with ultra-soft micro-baffles (thin, flexible discs) and has a smaller outer diameter. The micro-baffles gently fold along the trachea wall to comprehensively seal the airway while exerting less force than a balloon. In preliminary testing, RelianceET was 98% more effective than current ETTs in preventing leaks. Respair conducted over 300 interviews with clinicians and purchasers to map the needs of key stakeholders. What remains unknown is if the baffle sealing mechanism is safe and effective for pediatric airway sizes. This SBIR has two specific aims to achieve critical milestones that assess the feasibility of AssuranceET in pediatric airways. Aim 1: Develop high-fidelity pediatric airway models using CT scan reconstructions and 3D printing. Respair will develop high-fidelity pediatric airways using published data from CT scans to create clinically relevant test models for comparative testing of AssuranceET and competitor tubes. Aim 2: Complete comparative leak, tracheal pressure, and ventilatory pressure tests on AssuranceET prototypes and standard ETTs. Respair will test AssuranceET prototypes and competitors using enhanced test protocols to quantify critical safety metrics that validate the baffle sealing mechanism across pediatric airway sizes Completing these objectives will validate AssuranceET’s technical feasibility and safety, enabling Respair to reach a final design freeze. Respair aims to create a new standard for critical care by commercializing a safer and more effective endotracheal tube to improve outcomes for vulnerable patients on ventilators.