Optical sensor-enabled endotracheal tube to reduce esophageal intubation and unintended extubation

Project Summary/Abstract Over 30 million intubations are performed every year in the US. Unfortunately, improper endotracheal tube (ETT) placement (esophageal intubation) and insufficient ETT monitoring (unintended extubation) result in patient injury and ~$12B in unnecessary costs each year in the US. Delivery of respiratory support after intubation requires the ETT to be initially placed in the correct position and remain at this correct position post placement. Despite these two critical requirements for a life sustaining ETT, existing ETT and ETT position monitoring technologies do not provide adequate tracking during both initial placement and post placement monitoring. Therefore, this project’s ultimate objective is to develop a cost-effective optical sensor-enabled endotracheal tube (the OS-ETT) allowing both proper initial positioning and continuous positional monitoring of OS-ETT, which will substantially reduce the risk and incidence of esophageal intubation and unintended extubation. The OS-ETT’s optical sensors, signal processing algorithm, and visualization screen will present a real-time anatomical image allowing real-time OS-ETT positional tracking enabling both proper initial positioning and continuous positional monitoring. Furthermore, the OS-ETT’s optical sensors will be incorporated into a standard ETT minimizing workflow modifications and ensuring compatibility with existing respiratory support systems. Additionally, the OS- ETT will not require calibration or data input from the user. Lastly, the OS-ETT transmits positional information to a visualization screen allowing for remote monitoring. This SBIR Phase I application will demonstrate the feasibility of the OS-ETT by 1) optimizing the LED-photodiode array and signal processing algorithm for vocal cord identification and 2) evaluating the OS-ETT for vocal cord identification in the live porcine model. After completion of this SBIR Phase I project, Phase II will develop the image processing screen, conduct GLP testing, and complete standard biocompatibility, sterilization, and packaging validation tests in preparation for a First-in- Human clinical study.