Actuated, Low-Stress, Endotracheal Tube Cleaner to Improve Neonate Lung Function

描述（由申请方提供）：本I期SBIR开发并测试了主动Pedi ET-Clear系统，用于清洁直径为2.5 mm的新生儿气管插管中的粘液，与当前方法相比，对肺功能和力学的有害影响显著降低。Actuated Medical，Inc.是一家ISO 13485认证的医疗设备开发商，将主动运动技术集成到先进的医疗设备中。公共卫生问题：气管内导管（ETT）被放置在病人的气管时，他们无法呼吸自己。气管插管的一个主要并发症是肺部分泌物积聚，特别是呼吸机获得性肺炎（VAP）。在美国，估计ETT中的呼吸道分泌物每年影响107，000名新生儿和900，000名患者。ICU中最常见和致命的感染是VAP。VAP增加了呼吸机天数、重症监护和住院时间。为了去除粘液，可能在用生理盐水冲洗后，用抽吸导管抽吸ETT。与抽吸相关的风险包括缺氧（血液中含氧量低）、心动过缓（心率低）或肺不张（部分肺萎陷）。通常需要每1至4小时进行一次抽吸，这会使已经受损的患者的肺部紧张。肺容量因抽吸而减少，并导致气体交换受损和潜在的肺萎陷。新生儿气管插管内径窄至2.5 mm，需要频繁抽吸，并且难以在不阻塞气道的情况下进行清洁。需要一种设备来快速清洁新生儿管，同时最小化所需的抽吸压力并保持患者肺部的体积。第一阶段假设：Pedi ET-Clear Alpha原型在2.5 mm ETT中证明了与标准吸引导管相比的上级安全性（保留肺潮气量改善50%）和上级有效性（在相同时间内更清洁的ETT）。假设检验将采用<$= 0.05和<$<$0.20进行。第一阶段的具体目标：目标1：完成封闭系统设计并构建Alpha-II原型进行优化测试（第1 - 4个月）。目的2优化Pedi ET-Clear参数，以快速清除粘液，与当前吸引方法的基线影响相比，对肺潮气量的影响最小（第5 - 6个月）。目的3：在封闭式通气测试模型（第6个月）中，与新生儿临床医生的标准护理相比，Pedi ET-Clear性能的最终测试。

DESCRIPTION (provided by applicant): This Phase I SBIR develops and tests the active Pedi ET-Clear system to clean mucus from 2.5 mm diameter neonatal endotracheal tubes with significantly reduced deleterious impact on lung function and mechanics, as compared to current methods. Actuated Medical, Inc. is an ISO 13485-certified medical device developer integrating active motion technologies into advanced medical devices. Public Health Problem: Endotracheal tubes (ETT) are placed in a patient's trachea when they are unable to breathe on their own. A major complication of an ETT is the buildup of secretions from the lungs, with a particular concern for Ventilator Acquired Pneumonia (VAP). Respiratory secretions in ETTs are estimated to impact 107,000 neonatal and 900,000 total patients annually in the U.S. The most common and fatal infection in the ICU is VAP. VAP increases ventilator days, critical care and hospital lengths of stay. To remove mucus, the ETT is suctioned with a suction catheter, potentially after being flushed with saline. Risks associated with suctioning include hypoxia (low oxygen in blood), bradycardia (low heart rate), or atelectasis (collapse of part of the lung). Suctioning is often required every 1 to 4 hours and strains the lungs of an already compromised patient. Lung volume is reduced by the suctioning and results in impaired gas exchange and potential lung collapse. Neonatal ETTs, with inner diameters as narrow as 2.5 mm, require frequent suctioning and are difficult to clean without obstructing the airway. A device is needed for cleaning neonatal tubes quickly, while minimizing the suction pressure required and maintaining volume in the patient's lungs. Phase I Hypotheses: Pedi ET-Clear Alpha prototype demonstrates superior safety (e 50% improvement in retained lung tidal volume) and superior efficacy (cleaner ETT in the same amount of time) compared to standard suction catheter in 2.5 mm ETTs. Hypothesis testing will be performed with ¿ = 0.05 and ¿ ¿ 0.20. Phase I Specific Aims: Aim 1 Finalize Closed System Design and Construct Alpha-II Prototypes for Optimization Testing (Month 1 - 4). Aim 2 Optimize Pedi ET-Clear Parameters for Rapid Mucus Removal with Minimal Effect on Lung Tidal Volume Compared to Baseline Impact of Current Suctioning Methods (Month 5 - 6). Aim 3 Final Testing of Pedi ET-Clear Performance Compared to Standard Care with Neonatal Clinicians in Closed Ventilation Test Model (Month 6).