TRACHEAL GAS INSUFFLATION - PATIENT INTERFACE SYSTEM

气管充气 - 患者接口系统

• 批准号: 6788930
• 负责人: Robert Virag
• 金额: $ 10万
• 依托单位: ALVEOLI MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-05 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6788930
• 关键词: artificial respiration; bioengineering /biomedical engineering; biomedical equipment development; biomedical equipment safety; clinical biomedical equipment; evaluation /testing; health economics; health services research tag; patient safety /medical error; respirators; therapy compliance

DESCRIPTION (provided by applicant): The benefits of Tracheal Gas Insufflation (TGI) as an adjunct to mechanical ventilation are well known. 1 TGI reduces dead space and CO2 rebreathing in mechanically ventilated patients, thereby reducing PaCO2 with no change in minute ventilation, or maintaining PaCO2 with 10-20% reductions in minute ventilation.2 These improvements in ventilation efficiency are beneficial in avoiding or reducing the volutrauma associated with Acute Respiratory Distress Syndrome (ARDS). 3 Unfortunately, therapists are reluctant to adopt TGI as a conventional lung protection strategy. Reluctance to adopt TGI as a routine protocol is due primarily to the complexity and confusion surrounding its safe use, and to the lack of a simple and reliable patient interface.4 This study will define the feasibility of an integrated and easy-to-use patient interface system designed to improve the safety, ergonomics, compliance, ease of use, and costs associated with TGI. A simple add-on circuit will be designed to flush exhaled CO2 from the dead-space of conventional breathing circuits and thereby reduce the risk of morbidity typically associated with the misuse of complex self-made devices in clinical settings. Prototypes of the integrated TGI patient interface circuit will be designed, fabricated, and tested for performance and potential injury using a novel lung and trachea simulator. Design improvements will address issues identified by the FDA CDRH Anesthesiology Guidance Panel, December 1998.5 Safety features will include 1) a means to prevent over pressurization and barotrauma, 2) a simple means to provide heated and humidified flush gas, and 3) a means to safely integrate the multitude of pneumotachometer conduits, sensors, insufflations catheter, and gas humidifier with the patient breathing circuit and tracheal tube in an ergonomically effective package. Input requirements will be identified before the initiation of system design. Bench studies with the novel lung and tracheal model will verify design compliance to the input requirements and potentially reduce the number of future animal and human clinical studies needed to validate compliance to these requirements. This Phase I work will help justify a Phase II IDE clinical protocol with IRB approval for human-use clinical studies in the future. Development of this advanced TGI system will potentially lead to routine clinical use to help reduce or prevent the lung injury associated with mechanical ventilation and ARDS.

描述（由申请人提供）：气管充气（TGI）作为机械通气辅助手段的好处是众所周知的。 1 TGI 减少机械通气患者的死腔和 CO2 再呼吸，从而在每分钟通气量不变的情况下降低 PaCO2，或在每分钟通气量减少 10-20% 的情况下维持 PaCO2。2 这些通气效率的改善有利于避免或减少体积伤与急性呼吸窘迫综合征（ARDS）有关。 3 不幸的是，治疗师不愿意采用 TGI 作为传统的肺部保护策略。不愿采用 TGI 作为常规方案的主要原因是其安全使用的复杂性和混乱性，以及缺乏简单可靠的患者界面。 4 这项研究将确定集成且易于使用的患者界面系统的可行性，该系统旨在提高与 TGI 相关的安全性、人体工程学、合规性、易用性和成本。将设计一个简单的附加回路来冲洗传统呼吸回路死腔中呼出的二氧化碳，从而降低通常与临床环境中复杂自制设备的误用相关的发病风险。将使用新型肺和气管模拟器来设计、制造集成 TGI 患者接口电路的原型，并测试其性能和潜在伤害。设计改进将解决 FDA CDRH 麻醉学指导小组 1998 年 12 月确定的问题。5 安全功能将包括 1) 防止过压和气压伤的方法，2) 提供加热和加湿冲洗气体的简单方法，以及 3)将众多呼吸速度计导管、传感器、吹气导管和气体加湿器与患者呼吸回路和气管插管安全地集成在一个符合人体工程学的有效包装中。输入要求将在系统设计开始之前确定。使用新型肺和气管模型进行的基准研究将验证设计是否符合输入要求，并有可能减少未来验证是否符合这些要求所需的动物和人类临床研究的数量。 这项一期工作将有助于证明二期 IDE 临床方案的合理性，并获得 IRB 批准，用于未来的人类临床研究。这种先进的 TGI 系统的开发将有可能导致常规临床使用，以帮助减少或预防与机械通气和 ARDS 相关的肺损伤。