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）：众所周知，气管气体不体（TGI）作为机械通气的辅助功能的好处。 1 TGI可减少机械通风患者的死空间和二氧化碳的重新呼吸，从而减少PACO2而不会改变微小的通风或保持PACO2的变化，或者以10-20％的降低降低了PACO2。降低了10-20％的通风效率。这些提高通风效率的提高对避免或降低了与急性呼吸窘迫综合性（Ards）相关的volutrauma（Ards）。 3不幸的是，治疗师不愿意采用TGI作为常规的肺部保护策略。不愿采用TGI作为常规方案，主要是由于其安全使用的复杂性和混乱，以及缺乏简单可靠的患者界面。4 这项研究将定义旨在提高与TGI相关的安全性，人体工程学，合规性，易用性和成本的综合且易于使用的患者界面系统的可行性。一个简单的附加电路将设计为从传统呼吸电路的死空间中冲洗出呼出的二氧化碳，从而降低发病率通常与临床环境中滥用复杂的自制设备相关的发病率的风险。使用新型的肺和气管模拟器，将设计，制造和测试集成TGI患者界面电路的原型。 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符合人体工程学有效套件中的气管管。在启动系统设计之前，将确定输入要求。使用新型肺和气管模型进行的替补研究将验证设计符合输入要求的设计，并有可能减少验证符合这些需求所需的未来动物和人类临床研究的数量。 这一阶段的工作将有助于证明IID IDE临床方案的合理性，并在IRB批准将来批准人为临床研究。这种高级TGI系统的开发将有可能导致常规临床使用，以帮助减少或防止与机械通气和ARDS相关的肺损伤。