A Novel Nasogastric Feeding Tube for Optimizing Nutritional Administration in Older Adults

Period of Performance: 09/15/2017 - 08/31/2018

$225K

Phase 1 SBIR

Recipient Firm

Theranova, LLC
San Francisco, CA 94107
Principal Investigator

Abstract

Abstract Nasogastric enteral feeding is a non-invasive, life-saving therapy for older adults, who are unable to eat or swallow due to functional decline or age-related medical conditions, such as stroke. Every year, 230,000 nursing-facility and home-care residents and 10-30% of stroke patients in the United States receive enteral feedings. Nasogastric (NG) tubes are widely used, but pose a serious threat when erroneously inserted or dislodged (e.g. through tube curling) into organs other than the stomach. Several approaches are currently used for placement detection, however, these methods are limited by either their proven unreliability, high costs and/or risks. Even when NG tubes are safely positioned, an optimal amount of nutrition must be delivered at the right time for patients to thrive. However, tube-fed patients are subject to over-, under-, and delayed feedings with particularly acute complications in frail older adults. The most common nursing intervention to determine feeding rates is to periodically aspirate the gastric contents with a syringe and measure the total food and gastric fluid volume, also known as the gastric residual volume (GRV). However, this method is cumbersome and highly affected by user-, time- and patient-dependent factors. The residual food volume (RFV) has been found to be an alternative metric of gastric function, also known as gastric emptying. However, RFV detection methods are restricted in their use as well. For many patients, the risks and costs associated with the current GRV or RFV measurements outweigh the benefits. As such, there is an urgent need for an improved enteral feeding system that reduces risk, optimizes feeding and can be implemented in any medical care facility. TheraNova, LLC has developed a smart NG enteral feeding system dubbed ?Gravitas?, which can (1) automatically identify the device position between various tissues in real-time, assisting placement and alerting for tube dislodgment and (2) assess gastric and food volumes in real-time, enabling delivery of the right amount of food at the right time. The Gravitas prototype has demonstrated early feasibility through studies in healthy porcine and human subjects. The main goal of this project is to validate the Gravitas device on the bench and in vivo, and compare the device measurements with the current gold standards. After identifying the optimal electrode configuration of the device on the bench, we will verify the ability of the device to (1) differentiate between the stomach and other tissues and (2) accurately detect GRV and RFV in pigs. This research will ultimately allow caregivers to confidently insert the Gravitas feeding tube, act fast when the tube is directed in the wrong tissue and detect the gastric function to optimize food delivery in older adults.