Breathing Tube Position and Patency Monitoring System

呼吸管位置和通畅监测系统

• 批准号: 7326870
• 负责人: JEFFREY P MANSFIELD
• 金额: $ 100万
• 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 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7326870
• 关键词: Acoustics; Adopted; Adoption; Adult; Adverse event; Algorithms; Animals; Breathing; Capital; Caring; Chest; Child; Clinical; Clinical Research; Clinical Trials; Communities; Condition; Conduct Clinical Trials; Cost Savings; Data; Development; Devices; End Point; Enrollment; Funding; Goals; Grant; Growth; Human; INHBA gene; Injection of therapeutic agent; Intensive Care Units; Interleukin-5; Intubation; Journals; Label; Location; Measurable; Measures; Mechanical ventilation; Medical; Methodology; Molds; Monitor; Notification; Operative Surgical Procedures; Patients; Peer Review; Performance; Phase; Physiologic pulse; Placement; Population Study; Positioning Attribute; Procedures; Production; Publishing; Publishing Peer Reviews; Pulse taking; Randomized; Randomized Controlled Trials; Rate; Research; Respiratory distress; Risk; Safety; Secure; Standards of Weights and Measures; Suction; System; Techniques; Technology; Tube; United States Food and Drug Administration; Validation; base; clinical efficacy; commercialization; design; endotracheal; neonate; prevent; programs; prospective; prototype; respiratory; response; sound; tool

DESCRIPTION (provided by applicant): This project will evaluate the clinical efficacy and cost savings benefits from use of an endotracheal tube (ETT) position and patency monitoring system through a prospective, randomized, controlled trial conducted at multiple clinical centers. The two years, two phase study will enroll up to 270 subjects that include neonates, children, and adults who require intubation for extended ventilatory assistance. The system operation is based on an acoustic pulse-echo technique that non-invasively probes ETTs with sound and uses the returning echoes to determine the tube's position within the patient and provide quantitative information regarding tube patency. Phase I will verify safety and feasibility in approximately 50 subjects by programming the device to continuously collect ETT position and function data while the subject is mechanically ventilated, but blinding the research team to these data. Normal "standard of care" procedures will be used to maintain proper ETT function (e.g. routine chest x-rays to confirm ETT position, suctioning). Measurable results from these procedures will be compared to the data recorded on the device to determine consistency. Adverse events will be analyzed to determine if any were device related. If the results meet the safety and feasibility endpoints, Phase II will be initiated. Phase II will consist of a prospective, 1:1 randomized study of approximately 220 subjects in which the device will be used as a primary means to monitoring ETT location and function. Device data will be collected in addition to the standard of care measures performed on each subject. The primary hypothesis being investigated in this study is that use of this device will decrease the overall respiratory adverse event rate associated with mechanical ventilation. Secondarily, the data will be analyzed to determine if this device reduces adverse events associated with ETT position or function and predicts ETT-related adverse events prior to their occurrence. SonarMed's intelligent endotracheal tube (ETT) monitoring system has the potential to establish a new paradigm in the standard of care for airway management. It will enable clinicians to move from the current reactive approach that provides corrective action only in response to indirect indications of ETT complications (patient in respiratory distress), towards a more proactive methodology where immediate notification of high risk ETT conditions (ETT on verge of extubation) can be used to anticipate and thereby prevent adverse events.

描述（由申请人提供）：该项目将通过在多个临床中心进行的前瞻性，随机，对照试验来评估使用气管管（ETT）位置和通畅监测系统的临床功效和成本节省的好处。两年的两年研究将招收多达270名受试者，其中包括新生儿，儿童和需要插管进行扩展通气辅助的成年人。系统操作基于一种声学脉冲回波技术，该技术无创地探测声音的ETT，并使用返回的回声来确定试管在患者中的位置，并提供有关管通路的定量信息。第一阶段将通过对设备进行编程以在受试者进行机械通风时连续收集ETT位置和功能数据来验证大约50名受试者的安全性和可行性，但会使研究团队对这些数据蒙蔽。正常的“护理标准”程序将用于维持适当的ETT功能（例如，常规的胸部X射线以确认ETT位置，吸力）。这些过程的可测量结果将与设备记录的数据进行比较，以确定一致性。将分析不良事件，以确定是否与设备有关。如果结果符合安全性和可行性终点，则将启动II阶段。第二阶段将由前瞻性，1：1的随机研究组成，大约220个受试者将其用作监测ETT位置和功能的主要手段。除了对每个受试者执行的护理标准，还将收集设备数据。这项研究中研究的主要假设是，该设备的使用将降低与机械通气相关的总呼吸不良事件率。其次，将分析数据，以确定此设备是否会减少与ETT位置或功能相关的不良事件，并在发生之前预测与ETT相关的不良事件。 Sonarmed的智能气管内导管（ETT）监测系统有可能在气道管理标准中建立新的范式。它将使临床医生能够从目前的反应性方法转变，该方法仅对间接的ETT并发症（患者呼吸窘迫）提供纠正措施，转变为一种更为主动的方法，即立即通知高风险ETT条件（拔牙的边缘）可以预测，从而预测并防止不良事件。