Feasibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation

项目总结/摘要 SBIR的第一阶段提案侧重于改善临床医生和患者之间的沟通， 无创通气（NIV）治疗急性呼吸衰竭。医院环境中的无创通气是生命- 节省和高效，但它需要使用口罩，覆盖鼻子和嘴阻碍讲话。 这种口罩严重限制了患者的沟通。由于缺乏沟通，患者经常报告 感觉他们无法说出他们的护理需求，遭受高度焦虑，并且可能遭受更多 精神错乱创新的NIV附件（ReddyPort口腔入路肘管）将入路引入NIV 使用大的单向阀的面罩。使用这种FDA批准的阀门，可以将麦克风放入 面罩，允许患者自由地使用他们的声音进行交流，而不会中断NIV。在这份协议中，我们 本发明提出了对由麦克风模块组成的语音放大系统的改进和测试， 通过ReddyPort口腔进入弯头放入面罩，并连接到床边扬声器， 放大声音。我们计划改进语音清晰度系统，包括改进麦克风 模块，介绍了呼吸噪声消除系统，并设计了一个系统，用于自然化 病人的声音。然后，我们将在志愿者和患者身上测试该系统，以进一步验证该设备， 完善提高语音清晰度的制度。 在随后的第二阶段，该设备将在临床试验中进行测试，有效性终点包括 焦虑，投入，和精神错乱Axon的团队已经用几种设备证明了商业上的成功 并期待通过监管批准将该设备商业化，以减少 在急性呼吸衰竭这一危及生命的疾病期间，患者焦虑并改善参与度。

PROJECT SUMMARY/ABSTRACT This Phase 1 SBIR proposal focuses on improving communication between clinicians and patients undergoing noninvasive ventilation (NIV) for acute respiratory failure. Noninvasive ventilation in hospital settings is life- saving and highly effective, but it requires use of a mask that covers the nose and mouth obstructing speech. This mask severely limits patient communication. Because of this lack of communication, patients often report feeling they are unable to speak up about their care needs, suffer high levels of anxiety, and may suffer more delirium. An innovative NIV accessory (the ReddyPort Oral Access Elbow) has introduced access into the NIV mask utilizing a large one-way valve. Using this FDA-approved valve, a microphone can be placed into the mask to allow a patient to freely communicate using their voice without interrupting NIV. In this grant, we propose the improvement and testing of a voice amplification system consisting of a microphone module that is placed into the mask through the ReddyPort Oral Access Elbow and that connects to a bedside speaker that amplifies the voice. We plan to improve systems for voice intelligibility including improving the microphone module, introducing a breathing noise cancellation system, and designing a system for naturalizing the patient's voice. We will then test this system on both volunteers and patients to further iterate the device and perfect the systems for improving speech intelligibility. In a subsequent Phase II, the device will be tested in a clinical trial powered for efficacy endpoints including anxiety, engagement, and delirium. Axon's team has demonstrated commercial success with several devices and looks forward to bringing this device through regulatory approvals to commercialization in order to reduce patient anxiety and improve engagement during the life-threatening illness of acute respiratory failure.