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

无创通气期间促进患者沟通的麦克风系统的可行性测试

• 批准号: 9904380
• 负责人: Lara M Brewer
• 金额: $ 22.42万
• 依托单位: AXON MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9904380
• 关键词: Acoustics; Acute; Acute respiratory failure; Address; Adoption; Anxiety; Axon; Breathing; Caring; Clinical; Clinical Research; Clinical Trials; Communication; Critical Illness; Custom; Data; Delirium; Devices; Digital Signal Processing; Distress; Dyspnea; Elbow; Engineering; Environment; FDA approved; Failure; Family; Feeling; Grant; Health; Healthcare; Healthcare Systems; Hospitals; Human; Impairment; Interruption; Lead; Length of Stay; Life; Link; Masks; Medical; Methods; Modern Medicine; Noise; Nose; Oral; Oral cavity; Outcome; Pathological anxiety; Patient-Centered Care; Patient-Focused Outcomes; Patients; Performance; Phase; Physicians; Pneumonia; Positioning Attribute; Quality of Care; Reporting; Research Personnel; Savings; Sedation procedure; Small Business Innovation Research Grant; Speech; Speech Intelligibility; Speech Sound; System; Techniques; Technology; Testing; Time; Treatment Failure; Ventilator; Voice; Work; acute care; commercialization; design; experience; healthy volunteer; improved; innovation; microphone; multidisciplinary; negative affect; patient engagement; pressure; prototype; respiratory; seal; signal processing; sound; success; ventilation; volunteer

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.

项目概要/摘要 该 SBIR 第一阶段提案的重点是改善临床医生和接受治疗的患者之间的沟通 无创通气（NIV）用于治疗急性呼吸衰竭。医院环境中的无创通气至关重要 节省且高效，但需要使用遮盖鼻子和嘴巴的口罩，以防止说话。 这种面罩严重限制了患者的交流。由于缺乏沟通，患者经常报告 感觉他们无法说出自己的护理需求，遭受高度焦虑，并且可能遭受更多痛苦 谵妄。创新的 NIV 配件（ReddyPort 口腔接入弯头）引入了 NIV 接入方式 面罩采用大型单向阀。使用 FDA 批准的阀门，可以将麦克风放入 面罩，使患者能够在不中断 NIV 的情况下自由地使用语音进行交流。在这笔赠款中，我们 提出了由麦克风模块组成的语音放大系统的改进和测试，该系统是 通过 ReddyPort 口腔接入弯头放入面罩中，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，引入呼吸噪声消除系统，并设计一个自然化系统 病人的声音。然后，我们将在志愿者和患者身上测试该系统，以进一步迭代该设备并 完善语音清晰度提高体系。 在随后的第二阶段中，该设备将在临床试验中进行测试，以达到功效终点，包括 焦虑、投入和谵妄。 Axon 团队已通过多种设备展示了商业成功 并期待该设备通过监管部门批准进入商业化，以减少 患者焦虑并提高在急性呼吸衰竭危及生命的疾病期间的参与度。

项目成果

Using a novel in-mask non-invasive ventilator microphone to improve talker intelligibility in healthy and hospitalised adults.

使用新型面罩内无创呼吸机麦克风来提高健康和住院成人的讲话者的清晰度。

• 发表时间: 2023-10-13
• 作者: Young, Elizabeth D;Ferguson, Sarah Hargus;Brewer, Lara M;Schiedermayer, Benjamin F;Brown, Samuel M;Leither, Lindsay M
• 通讯作者: Leither, Lindsay M