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

驱动式低应力气管内插管清洁器可改善新生儿肺功能

基本信息

批准号：
8591919
负责人：
Roger Brooks Bagwell
金额：
$ 21.28万
依托单位：
ACTUATED MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-05 至 2015-03-04
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8591919
关键词：
Agreement Aspirate substance Atelectasis Bacteria Blood Bradycardia Brain hemorrhage Breathing Caliber Catheters Childhood Clinical Complication Critical Care Cyclic GMP Data Development Devices Distal Engineering Ensure Environmental air flow Equilibrium Evaluation Excision Family suidae Flushing Frequencies Funding Gases Heart Rate Hour Human Hypoxia Infection Intervention Irrigation Knowledge Length of Stay Letters London Lung Lung Compliance Maintenance Manufacturer Name Mechanics Medical Medical Device Medicine Methods Modeling Motion Mucous body substance Neonatal Newborn Infant Outcome Oxygen Patients Pediatric Hospitals Performance Phase Pneumonia Procedures Process Property Public Health Respiratory physiology Risk Safety Sales Saline Scientist Small Business Innovation Research Grant Sterility Street Child Stress Suction System Technical Expertise Technology Testing Thick Tidal Volume Time Trachea Tube Ventilation Test Ventilator base commercialization cost design design and construction endotracheal feeding improved innovation interest lung volume manufacturing scale-up meetings nasogastric feeding neonate operation pressure prototype public health relevance respiratory standard care stem verification and validation

项目摘要

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).

描述（由申请人提供）：第一阶段 SBIR 开发并测试了主动 Pedi ET-Clear 系统，用于清洁直径 2.5 毫米的新生儿气管插管中的粘液，与现有的 Actuated Medical 方法相比，该系统对肺功能和力学的有害影响显着减少。 , Inc. 是一家通过 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：气管插管 (ETT) 是一种常见的公共卫生问题。当患者无法自行呼吸时，将其置于气管中，ETT 的一个主要并发症是肺部分泌物的积聚，特别是对呼吸机获得性肺炎 (VAP) 的影响。美国每年有 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。增加呼吸机天数、重症监护和住院时间。为了清除粘液，可能会在用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（血氧含量低）、心动过缓（心率低）。）或肺不张（肺的一部分塌陷）通常每 1 至 4 小时需要进行一次抽吸，这会对已经受损的患者的肺部造成压力，导致肺容量减少。内径窄至 2.5 毫米的新生儿 ETT 需要频繁抽吸，并且难以在不阻塞气道的情况下进行清洁，同时最大限度地减少新生儿导管的堵塞。所需的抽吸压力和维持患者肺部的容量第一阶段假设：Pedi ET-Clear Alpha 原型表现出卓越的安全性（例如保留肺潮气量提高 50%）和卓越的功效。（在相同时间内更清洁的 ETT）与 2.5 mm ETT 中的标准抽吸导管相比假设测试将使用 ¿ = 0.05 和 ¿ ¿ 0.20. 第一阶段具体目标：目标 1 完成封闭系统设计并构建用于优化测试的 Alpha-II 原型（目标 2）优化 Pedi ET-Clear 参数，以实现快速粘液去除，与肺潮气量相比，影响最小当前抽吸方法的基线影响（第 5 - 6 个月目标 3）足部最终测试。新生儿临床医生在密闭通气测试模型（第 6 个月）中与标准护理相比的 ET-Clear 性能。