SBIR-STTR Award

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.

Public Health Relevance Statement:
Narrative Rapid initiation of enteral feeding via enteral feeding tubes (FTs) is essential to high-risk critically ill elderly patients, however, ensuring accurate FT location requires increased personnel time, increased healthcare costs and potentially detrimental delays in enteral nutrition. In previous studies, the Entarik System demonstrated real- time and accurate mapping of FT location. The goal of this Phase II proposal is to verify the performance of Entarik System to safely and effectively guide FT placement and monitor FT dislodgement in both healthy and critically ill older patients.

Project Terms:
Acids; Adoption; Age; ages; Elderly; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Aging; Algorithms; Automobile Driving; driving; Clinical Research; Clinical Study; Confusion; Confusional State; Mental Confusion; Critical Care; Critical Illness; Critically Ill; Cessation of life; Death; Economics; Enteral Nutrition; Environment; Esophagus; Feeding Methods; Future; Gastric Acid; Gastric Hydrochloric Acid; Goals; Gold; Health; Hospitals; Intensive Care Units; Iris; Lead; Pb element; heavy metal Pb; heavy metal lead; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Lung; Lung Respiratory System; pulmonary; Methods; Nursing; Nursing Field; Nursing Profession; Discipline of Nursing; nursing personnel; Nursing Staff; Patients; Pharynx; Throat; Pharyngeal structure; Aspiration Pneumonia; Research Resources; Resources; Risk; gastric; Stomach; Technology; Temperature; Time; United States; Work; Roentgen Rays; X-Radiation; X-Ray Radiation; X-ray; Xray; Health Care Costs; Health Costs; Healthcare Costs; Enteral Feeding; enteric feeding; feeding tube; gastric feeding; tube feeding; Gastric Feeding Tubes; Surgical Intensive Care; Specialist; Caring; Malnutrition; Nutritional Deficiency; Undernutrition; dietary deficiency; malnourished; nutrition deficiency; nutrition deficiency disorder; nutritional deficiency disorder; electric impedance; Electrical Impedance; Impedance; base; Pump; sensor; improved; Clinical; Phase; Medical; Ensure; Training; Failure; Recovery; Lung damage; pulmonary damage; pulmonary injury; pulmonary tissue damage; pulmonary tissue injury; lung injury; Hour; Event; System; Location; Performance; success; hazard; simulation; novel; Participant; Devices; Manpower; personnel; Human Resources; Abscission; Extirpation; Removal; Surgical Removal; resection; Excision; Position; Positioning Attribute; Admission; Admission activity; Modeling; Effectiveness; preventing; prevent; Enteric; Enteral; Kangaroo; Age-Years; Data; Detection; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; Nutritional; nutritious; Monitor; cost; older patient; elderly patient; Outcome; blind; Consumption; high risk; evidence base; Patient risk; high risk population; high risk group; radiological imaging; Radiography; Roentgenography; radiologic imaging; care costs; infection risk; mortality risk; death risk; Visualization; randomized controlled study; randomized control study

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.

Public Health Relevance Statement:
Narrative Rapid initiation of enteral feeding via enteral feeding tubes (FTs) is essential to high-risk critically ill elderly patients, however, ensuring accurate FT location requires increased personnel time, increased healthcare costs and potentially detrimental delays in enteral nutrition. In previous studies, the Entarik System demonstrated real- time and accurate mapping of FT location. The goal of this Phase II proposal is to verify the performance of Entarik System to safely and effectively guide FT placement and monitor FT dislodgement in both healthy and critically ill older patients.

Project Terms:
Acids; Adoption; ages; Age; advanced age; elders; geriatric; late life; later life; older adult; older person; senior citizen; Elderly; Aging; Algorithms; Automobile Driving; driving; Classification; Systematics; Clinical Research; Clinical Study; Confusion; Confusional State; Mental Confusion; Critical Care; Critical Illness; Critically Ill; Cessation of life; Death; Economics; economic; Enteral Nutrition; Environment; Esophagus; Feeding Methods; Future; Gastric Acid; Gastric Hydrochloric Acid; Goals; Health; Intensive Care Units; Iris; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Lung; Lung Respiratory System; pulmonary; Maps; Methods; Discipline of Nursing; Nursing; Nursing Field; Nursing Profession; Nursing Staff; nursing personnel; Patients; Pharyngeal structure; Pharynx; Throat; Aspiration Pneumonia; Resources; Research Resources; Risk; Stomach; gastric; Technology; Temperature; Time; United States; Work; Roentgen Rays; X-Radiation; X-Ray Radiation; X-ray; Xray; Health Costs; Healthcare Costs; Health Care Costs; enteric feeding; feeding tube; gastric feeding; tube feeding; Enteral Feeding; Gastric Feeding Tubes; Surgical Intensive Care; Specialist; Caring; Nutritional Deficiency; Undernutrition; dietary deficiency; malnourished; nutrition deficiency; nutrition deficiency disorder; nutritional deficiency disorder; Malnutrition; Electrical Impedance; Impedance; electric impedance; Tube; Pump; sensor; improved; Clinical; Phase; Medical; Ensure; Training; Failure; Recovery; Lung damage; pulmonary damage; pulmonary injury; pulmonary tissue damage; pulmonary tissue injury; lung injury; Hour; Event; System; Location; human old age (65+); 65+ years old; Aged 65 and Over; age 65 and greater; age 65 and older; aged 65 and greater; aged ≥65; old age; Performance; success; hazard; simulation; novel; Participant; Devices; Human Resources; Manpower; personnel; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Positioning Attribute; Position; Admission activity; Admission; Modeling; Effectiveness; preventing; prevent; Enteric; Enteral; Kangaroo; Age Years; Data; Detection; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Nutritional; nutritious; Monitor; cost; elderly patient; older patient; Outcome; blind; Consumption; high risk; evidence base; Patient risk; high risk group; high risk individual; high risk people; high risk population; Radiography; Roentgenography; radiologic imaging; radiological imaging; care costs; infection risk; death risk; mortality risk; Visualization; randomized control study; randomized, controlled study; hospital care; comparison control; compare to control