Adaptation of an Adult Endotracheal Tube Monitoring System for Use in Neonatal In

描述（由申请人提供）：新生儿气管插管与许多并发症相关，在美国每年造成超过2.5亿美元的直接成本，以及可能相当大的发病后成本，以及对父母和临床医生不可估量的情感成本。与成人相比，这一患者群体尤其脆弱，ETT的轻微移动到不适当的位置可能导致病情迅速恶化，有时会导致灾难性的后果。SonarMed开发了一种新型设备，使用基于声纳的技术，在成人重症监护病房提供关于气管内管位置和功能的精确、实时辅助信息。虽然这项被称为SonarMed“气道监测系统”（AMS）的技术将在成人ICU中提供好处，但其使用的最大影响预计将在新生儿中体验到，它将为临床医生提供无创和连续监测管道放置的能力，而无需使用x射线。这个拟议项目的长期目标是开发一种适用于新生儿的AMS。为了实现这一目标，第一步将是确定在新生儿重症监护室使用AMS的可行性。第一阶段项目将首先通过对新生儿重症监护室工作人员的调查来确定新生儿重症监护室用户的独特需求，使成人AMS适应新生儿重症监护室大小的elt，并收集动物和人类的声反射数据。声波反射数据将用于研究信号优化技术，并开发ETT位置跟踪算法的原型。在第一阶段之后，AMS将根据最终用户的要求进行重新设计，在临床研究中进行评估以显示安全性和有效性，最后提交给FDA进行市场许可。在美国，每年有超过43,000例新生儿重症监护病房插管，该产品的市场预计每年将超过1800万美元。

DESCRIPTION (provided by applicant): Endotracheal tube (ETT) intubation in neonates is associated with numerous complications which create immediate costs in excess of $250M annually in the U.S., as well as post-incidence costs that can be considerable, and immeasurable emotional costs to parents and clinicians. Compared to adults, this patient group is especially fragile where a slight movement of the ETT into an improper location can lead to rapid deterioration of their condition sometimes resulting in catastrophic consequences. SonarMed has developed a novel device using a sonar-based technique to provide precise, real-time adjunctive information regarding endotracheal tube position and function in the adult intensive care unit. While this technology, called the SonarMed" Airway Monitoring System (AMS), will provide benefits in the adult ICU, the greatest impact from its use is expected to be experienced in the neonate, where it will offer clinicians the ability to noninvasively and continuously monitor tube placement without the use of x-rays. The long-term objective of this proposed project is to develop an AMS appropriate for use in neonates. To accomplish this, the first step will be to determine the feasibility of adapting the AMS for use in the NICU. This Phase I project will focus on first determining the unique NICU user requirements through surveys with NICU personnel, adapting the adult AMS for NICU-size ETTs, and collecting acoustic reflection data in both animals and humans. The acoustic reflection data will then be used to investigate signal optimization techniques and develop a prototype ETT position tracking algorithm. Following Phase I, the AMS will be re-engineered based on the requirements established by the end-users, evaluated in clinical studies to show safety and efficacy, and finally submitted to the FDA for market clearance. With over 43,000 NICU intubations per year in the U.S., the market for this product is expected to be in excess of $18MM per year. PUBLIC HEALTH RELEVANCE: There are currently a number of challenges with using breathing tubes in premature infants. The consequences of these challenges are significant in terms of both health outcomes for the infant as well as costs to the U.S. healthcare system. This research will provide caregivers with a new monitoring tool intended to reduce the frequency and severity of complications associated with breathing tube use in premature infants.