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

描述(申请人提供)：新生儿气管插管(ETT)与许多并发症有关，在美国每年造成超过2.5亿美元的即时成本，以及可能相当可观的发病后成本，以及对父母和临床医生的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轻微移动到不适当的位置可能会导致他们的病情迅速恶化，有时会导致灾难性的后果。SonarMed开发了一种新型设备，该设备使用基于声纳的技术来提供有关成人重症监护病房中气管导管位置和功能的准确、实时的辅助信息。虽然这项名为SonarMed的呼吸道监测系统(AMS)将在成人ICU中提供好处，但它的使用预计将在新生儿中体验到最大的影响，在新生儿中，它将使临床医生能够在不使用X光的情况下无创地持续监测导管放置。这项拟议项目的长期目标是开发一种适合新生儿使用的AMS。要做到这一点，第一步将是确定将AMS改装用于NICU的可行性。这个第一阶段的项目将首先通过与NICU人员的调查来确定NICU用户的独特需求，调整成人AMS以适应NICU大小的ETT，并收集动物和人类的声反射数据。然后，声反射数据将被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将根据最终用户建立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FDA进行上市许可。在美国，每年有超过43,000例NICU插管，预计该产品的市场年销售额将超过1800万美元。 公共卫生相关性：目前在早产儿使用呼吸管方面存在许多挑战。这些挑战的后果无论是对婴儿的健康结果，还是对美国医疗体系的成本来说都是重大的。这项研究将为照顾者提供一种新的监测工具，旨在降低早产儿使用呼吸管相关并发症的频率和严重程度。

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.