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

摘要 在重症监护病房(ICU)，肠内营养(EN)是护理的关键组成部分，既提供营养 和非营养益处，包括降低感染风险、缩短住院时间和降低 死亡率。据估计，美国每年使用的喂养管(FT)超过120万根 交付恩恩。住院和重症监护入院人数随着年龄的增加而增加，导致65岁以上的患者 是ICU中受益于快速和一致的EN的最大亚群。现行的金本位 FT置放方法，床边盲置，导致首次置放失败8%-60%(平均 32.3%)。如果没有发现，这些错位可能会导致严重的患者伤害。因此，射线照相 需要进行验证才能确认正确的FT定位。由于尝试失败的比率很高，固有的 与重复X光检查相关的延误不仅会增加人员时间和医疗保健成本，还可能导致 对于早期肠内营养至关重要的患者来说，结果不太理想。一旦放置，就会发生意外的FT移位 在多达33%-63%的FTs中，如果EN进入咽部或 肺部。因此，英国《金融时报》的职位必须由重症监护人员定期核实，如有必要，必须重新插入 安置确认，所有这些都导致对护理时间的需求增加，增加了成本和延误 嗯。为了减少错位的发生，最近开发了智能FT系统，但高 使用这些设备所需的成本和专业知识/培训限制了它们的临床应用。此外，这些 智能系统不会监控英国《金融时报》的移位。因此，仍然迫切需要一份智能的金融时报 易于使用、价格低廉、全面的患者护理解决方案。TheraNova已经开发出了这个 Entaik系统中的解决方案，这是一种低成本的肠道喂养系统，可提供FT的实时确认 床边的位置，用于插入引导和取出管理。在我们之前的工作中， Entailk系统(1)在临床研究中对呼吸道、食道和胃进行了准确的分类(2) 检测到FT从胃移位到食道，以及(3)证明可靠、持久 在长椅上模拟胃环境的表现。在此第二阶段提案中，我们将验证外管局 以及在健康和危重患者中有效的FT放置和移位检测。以特定的目标 一项在健康受试者胃酸抑制前后进行的临床研究将验证这一准确性 在引导FT放置和移位检测方面都有很大的优势。在具体目标2中，随机、对照 将进行研究，以验证Entaik系统在老龄化内外科ICU中的性能 患者，因为这代表了大量FT错位的高危患者。成功者 拟议工作的完成将支持510(K)批准Entaurk系统，以指导FT安置 而不需要X光确认。作为一个低成本和易于使用的系统，性能数据将支持 我们的设备是当前智能FTs的全面优势选项，推动了临床采用。

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.