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. If undetected, these misplacements can lead to serious patient harm. As such, radiographic 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. Once placed, unintentional FT dislodgement occurs in as many as 33-63% of FTs and has the potential to be a serious hazard if EN is delivered into the pharynx or lungs. Thus, FT position must be routinely verified by critical care staff and, if necessary, re-inserted with placement confirmation, all of which results in increased demand on nursing time, increased cost and delayed EN. To reduce the occurrence of misplacement, smart FT systems have recently been developed, but the high costs and expertise/training required to use these devices have limited their clinical adoption. Further, these smart systems do not monitor for FT dislodgement. 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 this solution in 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. In our previous work, the Entarik System (1) accurately classified the airway, esophagus and stomach in a clinical study (2) accurately detected dislodgement of the FT into the esophagus from the stomach and (3) demonstrated reliable, durable performance in a bench simulation of the gastric environment. In this Phase II proposal, we will validate the safe and effective FT placement and dislodgement detection in both healthy and critically ill patients. In Specific Aim 1, a clinical study in healthy participants prior to and following gastric acid suppression will validate the accuracy of Entarik in both guided FT placement and dislodgement detection. In Specific Aim 2, a randomized, controlled study will be conducted to validate the performance of the Entarik System in aging medical and surgical ICU patients, as this represents a large population of high-risk patients for FT misplacement. The successful completion of the proposed effort will support 510(k) clearance of the Entarik System for guiding FT placement without the need for x-ray confirmation. As a low-cost and easy-to-use system, the performance data will support that our device is an overall superior option to current smart FTs, driving clinical adoption.