Improved Systems for Respiratory Support

项目概要/摘要 明尼苏达州健康解决方案公司（MHS）和洛杉矶儿童医院（CHLA）提出， 开发和验证一种新的系统，用于创建定制的呼吸接口器具， 目的是改善重症监护室（ICU）中婴儿和儿童的无创通气（NIV）。 NIV的技术进步改善了重症患者的预后，但不幸的是， 新生儿和儿童不能获得NIV的全部益处，特别是双水平通气，因为他们 不能有效地使呼吸与无创呼吸机同步。这是因为儿科NIV患者 接口器具通常具有显著的空气泄漏，当结合儿童 在气道流量中产生较小的变化，阻止呼吸机可靠地感测患者的努力。的 导致呼吸机呼吸与患者努力不同步，导致无效通气，患者 呼吸困难，肺损伤加重为了克服过度泄漏和不充分触发， 临床医生经常收紧接口，导致皮肤破裂和压力性溃疡。NIV相关压疮 正在成为重症监护室最常见的并发症之一。缺乏有效的NIV领导 新生儿和幼儿的插管率较高，不必要地暴露于药物， 损害发育中的大脑，ICU住院时间延长，以及医源性并发症，如感染，呼吸机 引起的横膈膜功能障碍和ICU后生活质量受损。呼吸机制造商 寻找解决这个问题的方法，因为许多以前开发的产品没有获得 由于它们是侵入性的或在应用于 婴儿或新生儿。拟议的项目将开发和评估一个创新的系统， 生产定制的NIV呼吸接口。

Project Summary/Abstract Minnesota HealthSolutions Corporation (MHS) and Children’s Hospital Los Angeles (CHLA) propose the development and validation of a novel system for creating custom-fit respiratory interface appliances for the purpose of improving non-invasive ventilation (NIV) for infants and children in the intensive care unit (ICU). Technology advancements in NIV have improved outcomes for critically ill patients, but unfortunately, most neonates and children do not achieve the full benefits of NIV, particularly bi-level ventilation, because they are unable to effectively synchronize breaths with the non-invasive ventilator. This is because pediatric NIV patient interface appliances often have significant air leakage, which, when combined with the fact that children generate smaller changes in airway flow, prevents the ventilator from reliably sensing patient effort. The resulting ventilator breaths are asynchronous with patient effort, leading to ineffective ventilation, higher patient effort of breathing, and worsening lung injury. To overcome excessive leakage and inadequate triggering, clinicians often tighten interfaces, resulting in skin breakdown and pressure ulcers. NIV related pressure ulcers are becoming amongst the most common complications in intensive care units. The lack of effective NIV leads to higher rates of intubation in neonates and young children, with unnecessary exposure to medications which harm the developing mind, longer ICU lengths of stay, and iatrogenic complications such as infection, ventilator induced diaphragm dysfunction, and post-ICU impairment in quality of life. Ventilator manufacturers are searching for solutions to this problem because many previously developed products have not gained widescale commercial use since they are invasive or have substantial technical limitations when applied to the infant or neonate. The proposed project will develop and evaluate an innovative system for rapid in-hospital production of custom-fit NIV respiratory interfaces.