Continuous Blood Pressure Monitor

连续血压监测仪

• 批准号: 9205403
• 负责人: Slawomir Marian Lobodzinski
• 金额: $ 24.85万
• 依托单位: LOGAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9205403
• 关键词: 3-Dimensional; Accelerometer; Acute; Address; Adult; Affect; Ally; Ambulatory Blood Pressure Monitoring; Antihypertensive Agents; Apnea; Arousal; Arrhythmia; Arterial Lines; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Blood pressure determination; Calibration; Cannulas; Cardiovascular system; Caring; Cerebrum; Chest; Chronic; Chronic Obstructive Airway Disease; Chronically Ill; Clinical; Clinical Trials; Collection; Data; Development; Devices; Diastolic blood pressure; Disease Progression; Economic Inflation; Electrodes; Electronics; Emergency Situation; Epilepsy; Equipment; Evaluation; Future; Head; Healthcare; Healthcare Market; Heart Rate; Heart Sounds; Hemorrhage; Home environment; Human; Hypertension; Hypotension; Individual; Interruption; Intervention; Life; Measures; Medicare; Medicine; Methodology; Monitor; Morphologic artifacts; Movement; Myocardial Infarction; Neonatal; Neurology; Obstructive Sleep Apnea; Operative Surgical Procedures; Output; Patient Monitoring; Patients; Performance; Pharmaceutical Preparations; Phase; Physiologic pulse; Population; Prevalence; Procedures; Process; Reading; Research; Resistance; Risk; Secure; Shapes; Shock; Sleep; Sleep Apnea Syndromes; Small Business Innovation Research Grant; Sudden Death; Techniques; Time; Tissues; United States National Institutes of Health; Validation; Variant; Wireless Technology; Wrist; base; blood pressure regulation; cost; data exchange; design; improved; injured; insight; meetings; monitoring device; neonate; premature; pressure; prototype; respiratory; sensor; user-friendly; wearable technology

The objective is to develop a wireless, wearable device for non-invasive assessment of continuous, long-term (multi-day) beat-by-beat systolic and diastolic blood pressure (BP) in humans without use of cuff inflation or other arousing or activity-interfering stimulation. The proposed non-invasive continuous BP (CBP) methodology addresses an unmet need for determination of extreme transient BP changes during obstructive sleep apnea, following ictal periods with potential hypotension leading to sudden death in epilepsy, momentary pressure changes in chronic hypertension and hypotensive patients, and numerous other cardiovascular and respiratory conditions where BP changes accompany disease progression. The device will be useful in patients who are likely to display sudden changes in blood pressure (e.g. vascular surgery), in whom close control of blood pressure is required (e.g. head-injured patients), or in patients receiving drugs to maintain blood pressure. Collectively, the health care needs of over half of the US population at some point in their life could benefit from the device. CBP monitoring provides numerous advantages. The device is very low cost, allowing ready replacement of ambulatory cuff-based 24hr devices. Instead of the intermittent, spotty collection and arousal induction of automated BP cuff monitors, the device offers continuous (i.e., beat-by- beat) data, an obvious advantage in BP assessment during sleep or surgery. The CBP technique allows accurate blood pressure readings at very low pressures, for example, during shock, a critical aspect in emergency transport or care circumstances, or in surgery. The device is wireless, avoiding multiple electrode placements, requires only a single thoracic and wrist placed sensor, and thus significantly improves patient comfort, especially in long-term blood pressure monitoring, e.g. ICU or chronically-ill home-based patients; moreover, repeated cuff inflations are avoided. The sensor design allows estimates of intravascular volume status from the wave shape of the arterial pressure data, providing valuable insights into cardiovascular dynamics and BP measures, which are impervious to distortions commonly induced by pulse transit time BP-inference devices due to heart rate variations. In this Phase I proposal, we will continue to develop the prototype, and provide initial validation in patients with intra-arterial line BP data to CBP undergoing cardiovascular procedures, and in a set of three levels of ambulatory hypertensive patients. The initial clinical evidence will provide support for a later Phase II proposal in a full clinical trial.

目标是开发一种无线可穿戴设备，用于非侵入性评估 连续、长期（多天）逐次心跳的收缩压和舒张压 (BP) 人类无需使用袖带充气或其他唤醒或干扰活动的刺激。这 提出的非侵入性连续血压 (CBP) 方法解决了未满足的需求 发作后阻塞性睡眠呼吸暂停期间极端短暂血压变化的测定 潜在低血压导致癫痫猝死、瞬时压力的时期 慢性高血压和低血压患者以及许多其他心血管疾病的变化 以及血压随疾病进展而变化的呼吸系统疾病。该设备将 对于可能出现血压突然变化的患者（例如血管性血压变化）非常有用 手术），需要密切控制血压的人（例如头部受伤的患者），或 接受药物维持血压的患者。总的来说，超过 一半的美国人口在一生中的某个时刻可能会从该设备中受益。 CBP 监测具有许多优势。该设备成本非常低，可以随时 更换基于袖带的 24 小时动态设备。而不是断断续续、参差不齐的收集 和自动血压袖带监测器的唤醒感应，该设备提供连续（即逐搏） 节拍）数据，在睡眠或手术期间血压评估方面具有明显优势。 CBP 技术可以在非常低的压力下获得准确的血压读数， 例如，在休克期间、紧急运输或护理情况下的一个关键方面，或者在 外科手术。该设备是无线的，避免了多个电极放置，只需要一个 胸部和手腕放置传感器，从而显着提高患者的舒适度，特别是在 长期血压监测，例如ICU 或长期患病的家庭患者；而且， 避免了袖带反复充气。传感器设计可以估计血管内容量 从动脉压数据的波形中了解状态，提供有价值的见解 心血管动力学和血压测量，通常不受扭曲影响 由于心率变化，由脉搏传导时间血压推断装置引起。 在第一阶段提案中，我们将继续开发原型，并提供初步验证 在接受心血管手术时向 CBP 提供动脉内血压数据的患者，以及 一组三个级别的动态高血压患者。初步临床证据将提供 支持稍后在完整临床试验中进行的第二阶段提案。