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.
