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，评价使用气管插管（ETT）位置和通畅性监测系统的临床疗效和成本节约效益。这项为期两年的两阶段研究将入组多达270例受试者，包括需要插管以获得长期辅助的新生儿、儿童和成人。系统操作基于声学脉冲回波技术，该技术使用声音无创地探测气管插管，并使用返回的回波来确定插管在患者体内的位置，并提供有关插管通畅性的定量信息。I期将通过对器械进行编程，在受试者接受机械通气时持续收集ETT位置和功能数据，但对研究团队的这些数据设盲，验证约50例受试者的安全性和可行性。将使用正常的“标准治疗”程序来维持适当的ETT功能（例如，常规胸部X线检查以确认ETT位置、抽吸）。将这些程序的可测量结果与器械上记录的数据进行比较，以确定一致性。将对不良事件进行分析，以确定是否与器械相关。如果结果符合安全性和可行性终点，将启动II期研究。II期将包括一项约220例受试者的前瞻性、1：1随机研究，其中器械将用作监测ETT位置和功能的主要手段。除了对每例受试者进行的标准治疗措施外，还将收集器械数据。本研究中研究的主要假设是使用该器械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，以确定该器械是否减少了与气管插管位置或功能相关的不良事件，并在发生之前预测气管插管相关不良事件。SonarMed的智能气管插管（ETT）监测系统有可能在气道管理的护理标准中建立一个新的范例。它将使临床医生能够从目前仅针对ETT并发症的间接指征（呼吸窘迫患者）提供纠正措施的反应性方法转向更积极主动的方法，其中立即通知高风险ETT状况（即将拔管的ETT）可用于预测并从而预防不良事件。

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.