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.

Grant Number: 1R43HL182517-01
NIH Institute/Center: NIH
Principal Investigator: Ross Beresford