Breathing Tube Position and Patency Monitoring System

描述（由申请人提供）：本项目将通过在多个临床中心进行的前瞻性、随机、对照试验，评估使用气管插管（ETT）位置和通畅监测系统的临床疗效和成本节约效益。这项为期两年的两期研究将招募270名受试者，包括需要插管进行延长呼吸辅助的新生儿、儿童和成人。该系统的操作基于声学脉冲回波技术，该技术无创地探测具有声音的导管，并使用返回的回声来确定导管在患者体内的位置，并提供导管通畅的定量信息。第一阶段将在大约50名受试者中验证安全性和可行性，方法是对设备进行编程，使其在受试者处于机械通气状态时持续收集ETT位置和功能数据，但不让研究团队了解这些数据。正常的“标准护理”程序将用于维持正常的气管插管功能（如常规胸部x光片以确认气管插管位置，吸痰）。这些程序的可测量结果将与设备上记录的数据进行比较，以确定一致性。将分析不良事件，以确定是否有任何与设备有关。如果结果满足安全性和可行性终点，将启动II期。第二阶段将包括一项约220名受试者的前瞻性1:1随机研究，该设备将作为监测ETT位置和功能的主要手段。除了对每个受试者执行的标准护理措施外，还将收集设备数据。本研究调查的主要假设是，使用该设备将降低与机械通气相关的总体呼吸不良事件发生率。其次，将对数据进行分析，以确定该装置是否减少与ETT位置或功能相关的不良事件，并在ETT相关不良事件发生之前预测其发生。SonarMed的智能气管内管（ETT）监测系统有可能在气道管理的护理标准中建立新的范例。它将使临床医生能够从目前的反应性方法（仅针对ETT并发症的间接指征（呼吸窘迫患者）提供纠正措施）转向一种更主动的方法，即立即通知高风险ETT情况（ETT即将拔管），从而预测并预防不良事件。

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.