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

成人气管插管监测系统在新生儿中的应用

• 批准号: 8064344
• 负责人: JEFFREY P MANSFIELD
• 金额: $ 22.46万
• 依托单位: SONARMED, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8064344
• 关键词: Accident and Emergency department; Acoustics; Adoption; Adult; Adverse event; Algorithms; Anesthesia procedures; Animal Model; Animals; Breathing; Bronchi; Caregivers; Childhood; Clinical; Clinical Research; Clinical Trials; Collecting Tube; Complication; Data; Deposition; Deterioration; Devices; Emotional; Engineering; Esophagus; Excision; Frequencies; Health; Healthcare Systems; Hospitals; Human; Human Resources; Incidence; Infant; Intensive Care Units; Intubation; Lead; Length of Stay; Life; Location; Marketing; Mechanical ventilation; Methods; Modification; Monitor; Movement; Mucous body substance; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Nosocomial pneumonia; Obstruction; Operating Rooms; Outcome; Parents; Patients; Phase; Population; Positioning Attribute; Premature Infant; Quality of Care; Research; Respiration; Safety; Severities; Signal Transduction; Surveys; System; Techniques; Technology; Testing; Time; Trachea; Tube; base; cost; design; endotracheal; experience; improved; infant outcome; innovation; meetings; neonate; novel; prototype; public health relevance; respiratory; routine care; sonar; sound; tool

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.

描述（由申请人提供）：新生儿的气管插管（ETT）插管与许多并发症有关，这些并发症在美国每年的立即成本超过2.5亿美元，而后的成本可能会很大，并且对父母和临床医生的情感成本不高。与成年人相比，该患者群体尤其脆弱，其中ETT轻微移动到不当的位置可能导致病情快速恶化，有时会导致灾难性后果。 Sonarmed使用基于声纳的技术开发了一种新型的设备，以提供有关气管管的位置和功能的精确实时辅助信息。虽然这项被称为“呼吸道监控系统（AMS）”的技术将在成人ICU中提供好处，但预期其使用的最大影响有望在新生儿中经历，它将为临床医生提供非侵入性和连续监控的管子放置的能力，而无需使用X射线的长期目标。通过使用NICU人员调查，将AM用于NICU的AMS将首先确定NICU用户的需求，从而使成年AMS适应NICU大小的ETT，并收集动物和人类的声音protike Importipe impotipe the Perace importipe image the Peraime impotipe image the Peraiment Image Insipe image Imperipe tosement Image the Ope。根据最终用户建立的要求进行重新设计，并在临床研究中评估以显示安全性和有效性，并最终提交给FDA以进行市场清算，每年有超过43,000个NICU插管，该产品的市场预计每年将超过$ 18mm。 公共卫生相关性：目前在早产婴儿中使用呼吸管的挑战存在许多挑战。这些挑战的后果在婴儿的健康成果以及美国医疗保健系统的成本方面都很重要。这项研究将为护理人员提供一种新的监测工具，旨在降低与早产婴儿呼吸管相关的并发症的频率和严重性。