312 Developing a Digitally Integrated Endotracheal Tube for Neonates to Improve Safety and Respiratory Function

OBJECTIVES/GOALS: Neonatal endotracheal tubes (ETTs) are usually uncuffed to avoid subglottic stenosis and other complications, but cuffed ETTs allow better ventilation. Our goal was to detect and control pressure in the cuff below the limit of occluding venous flow to minimize the risk of subglottic stenosis. METHODS/STUDY POPULATION: We designed a pressure sensor to fit on a 2.5 ETT for prototype testing in 8 age adult female rabbits. Eight uncuffed age- and sex- matched rabbits served as control. Study duration was 2 hours during which pressure in the cuff was limited by novel sensor (intervention) or auscultation (control). Anesthesia was maintained with sevoflurane. Ventilation was provided mechanically. Subsequently the tracheae were removed, sectioned crosswise, and compared histologically for mucosal damage. RESULTS/ANTICIPATED RESULTS: Preliminary data demonstrated an almost 30% greater amount of intact mucosa in the intervention group. The sensor also provided data on heart rate and respiratory rate, although this signal was not optimal. After filing an invention disclosure and provisional patent, we are refining our device to include multiple compartments for local control of cuff pressure and applying for a STTR Phase I/II application. DISCUSSION/SIGNIFICANCE: Ventilation in neonates with uncuffed ETTs can be suboptimal due to leak around the tube, but cuffed ETTs pose the threat of subglottic stenosis and other complications. We have designed a prototype cuffed ETT with a sensor to maintain low cuff pressure while preventing leaks and largely avoiding damage to the tracheal mucosa.