A novel enteral feeding system for the earlier and safer delivery of enteral nutrition through continuous monitoring of tip location

Abstract In the intensive care unit (ICU), enteral nutrition (EN) is a critical component of care that provides both nutritional and non-nutritional benefits including decreased risk of infection, shorter hospital stay and decreased risk of mortality. It is estimated that more than 1.2 million feeding tubes (FTs) are used each year in the United States to deliver EN. Hospital and critical care admittance increase with age resulting in patients older than 65 years being the largest subpopulation within the ICU to benefit from rapid and consistent EN. The current gold standard method for FT placement, blind bedside insertion, results in first attempt placement failure in 8-60% (Average 32.3%) of cases, which can result in the distal tip lying in the respiratory tract, esophagus or lung. While lung placement occurs in 1-3% of overall FT placements, the incidence is an order of magnitude higher at 13-20% in high-risk patients including critical ill-, older- or mechanically ventilated-patients due to delayed patient response, weakened coughing reflex and altered mental status. If undetected, these misplacements can lead to serious patient harm. As such, x-ray verification is required to confirm the correct FT positioning. With the high rate of failed attempts, the inherent delays associated with repeated x-rays not only add to personnel time and health care costs but can lead to suboptimal outcomes for patients where early EN is critical. Smart FT systems have been developed to provide real-time visualization during FT insertion. While they have demonstrated a reduction in the number of confirmatory XRays and a benefit with respect to earlier EN, there remains significant risk as operators have failed to accurately identify airway insertion resulting in patient injury and death. Further, once placed, unintentional FT dislodgement occurs in as many as 33-63% of FTs which requires routine verification resulting in increased cost and delayed EN. Thus, there is still an urgent need for a smart FT that is an easy-to- use, inexpensive, and comprehensive solution for patient EN care. TheraNova has developed the Entarik System, a low-cost enteral feeding system that provides real-time confirmation of FT location at the bedside for both insertion guidance and dislodgement management. Through the support from our Phase I and Phase II SBIR awards we have made substantial progress. The Entarik System is validated for (1) accurate classification of the airway, esophagus and stomach, (2) accurate dislodgement detection and (3) reliable, durable performance for the FT lifetime. Entarik was recently awarded 510k clearance by the FDA. In this proposal, we will prepare for commercialization through three specific aims. First, we will verify detection of shallow airway insertion (prior to an insertion depth that would induce harm) in intubated patients ventilated with heated and humidified air (Aim 1). Second, we will design a second-generation (Gen 2) FT with improved reduced cost of goods sold (COGS) to enable commercial launch (Aim 2). Finally, we will complete verification and validation testing and submit a new 510(k) application to the FDA for the Gen 2 system (Aim 3). The successful completion of these aims will enable commercialization of a cost effective solution within ~2 years of funding from this proposal.