Breathing Tube Position and Patency Monitoring System

呼吸管位置和通畅监测系统

• 批准号: 7169578
• 负责人: JEFFREY P MANSFIELD
• 金额: $ 31.43万
• 依托单位: SONARMED, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-01 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7169578
• 关键词: Acoustics; Address; Adult; Animals; Body cavities; Breathing; Caliber; Canis familiaris; Caring; Catheters; Chest; Clinical; Clinical Trials; Condition; Consult; Depth; Development; Direct Costs; Engineering; Ensure; Environmental air flow; Facilities and Administrative Costs; Funding; Goals; Grant; Human; In Vitro; Infant; Injection of therapeutic agent; Intubation; Licensing; Liquid substance; Location; Marketing; Medical Device; Membrane; Methods; Microprocessor; Molds; Monitor; Morbidity - disease rate; Mucous body substance; Obstruction; Oryctolagus cuniculus; Patients; Performance; Phase; Physiologic pulse; Placement; Positioning Attribute; Principal Investigator; Procedures; Pulse taking; Quality of Care; Research; Risk; Standards of Weights and Measures; Suction; System; Techniques; Technology; Testing; Trachea; Transducers; Tube; United States Food and Drug Administration; Universities; Water; body cavity; clinically relevant; concept; cost; design; endotracheal; improved; in vivo; millimeter; mortality; new technology; prophylactic; prototype; research and development; sensor; size; sound; tool; vapor; vocal cord

DESCRIPTION (provided by applicant): The long-term objective of this project is to commercialize an endotracheal tube (ETT, breathing tube) incorporating a technology which can provide a multitude of clinically relevant information to aid in airway management. The system consists of a low-cost, disposable ETT containing several miniature sensors that are connected to an embedded microprocessor. The system can provide: instantaneous confirmation of proper tube placement during intubation (in breathing or non-breathing patients); quantification of ETT insertion depth past the vocal folds to within millimeters; location and degree of partial or full obstructions within the ETT lumen; appropriateness of ETT diameter fit to the trachea; and location of a suction catheter tip within the ETT lumen during suctioning. It is expected that this airway management tool will establish a new standard of care for the intubated patient by continuously monitoring the condition and position of ETTs thereby ensuring a clear and intact airway. Clinical use of these tubes can potentially reduce both the direct costs (e.g. chest x-rays to confirm tube placement, prophylactic suctioning procedures) and indirect costs (e.g. resulting from morbidity and mortality) associated with ETT use. A prototype of the system, which can be applied equally to adult and infant sized ETTs, has been evaluated in preliminary animal and human infant studies with excellent results. However, the prototype is not robust or miniature enough for clinical use and thus requires additional research before moving forward. The key phase I aim is to conduct in vitro studies to design and develop an optimal miniature system while ensuring that the design can be mass produced at a low cost. Successful completion of this aim will significantly reduce the technology risk associated with the phase II development of a reliable and low-cost commercial system.

描述（由申请人提供）： 该项目的长期目标是将气管内管（ETT，呼吸管）商业化，该技术结合了一项技术，该技术可以提供多种临床相关信息以帮助气道管理。该系统由一个低成本的一次性ETT组成，其中包含几个连接到嵌入式微处理器的微型传感器。该系统可以提供：插管期间（呼吸或非呼吸患者）瞬时确认适当的管子放置；量化ETT插入深度的量化，经过声带折叠到毫米内； ETT管腔内的部分或全部障碍物的位置和程度； ETT直径适合气管的适当性；吸力导管尖端在吸力过程中的位置。预计该气道管理工具将通过不断监视ETT的状况和位置，从而确保清晰且完整的气道通过不断监视ETT的状况和位置，为插管患者建立新的护理标准。这些管的临床使用可能会降低直接成本（例如胸部X射线，以确认试管放置，预防吸力程序）和与ETT使用相关的间接成本（例如，发病率和死亡率）。该系统的原型可以同样应用于成人和婴儿大小的ETT，已在初步动物和人类婴儿研究中进行了评估。但是，该原型不足以稳健或不足以供临床使用，因此需要在进行前进之前进行其他研究。关键阶段的目标是进行体外研究，以设计和开发最佳的微型系统，同时确保可以低成本生产设计。成功完成此目标将大大降低与可靠且低成本商业系统的II期开发相关的技术风险。