Momitor: Wearable Technology for Early Detection of Postpartum Hemorrhage

Momitor：用于早期发现产后出血的可穿戴技术

• 批准号: 10483278
• 负责人: Christine Rohan
• 金额: $ 24.47万
• 依托单位: VASOWATCH LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483278
• 关键词: Address; Admission activity; Adoption; Affect; Algorithms; Atopobium vaginae; Birth; Birthing Centers; Blood; Blood Circulation; Blood Transfusion; Blood Volume; Cesarean section; Charge; Childbirth; Clinical; Clinical Management; Data; Data Collection; Detection; Deterioration; Devices; Early Diagnosis; Ensure; Fees; Funding; Future; Hemorrhage; Hemorrhagic Shock; Hospitals; Hour; Hypovolemia; Income; Insurance Carriers; Intensive Care; Intervention; Leg; Length of Stay; Life; Limb structure; Link; Literature; Maternal Mortality; Measures; Minority Groups; Monitor; Morbidity - disease rate; Mothers; Observational Study; Operating Rooms; Organ; Patient Care; Patient-Focused Outcomes; Patients; Pennsylvania; Pharmaceutical Preparations; Phase; Photoplethysmography; Postpartum Hemorrhage; Postpartum Period; Postpartum Women; Race; Radio; Risk; Running; Small Business Technology Transfer Research; Suggestion; Symptoms; System; Techniques; Time; United States National Institutes of Health; Vaginal delivery procedure; Visual; Woman; Workload; algorithm development; arm; base; clinical decision support; clinical risk; clinically actionable; cloud based; cost; dashboard; direct application; early screening; improved outcome; mortality; patient tolerability; peripheral blood; prototype; response; smart watch; standard of care; transmission process; trauma care; wearable device; wireless fidelity

Abstract: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide and disproportionately affects minority populations. PPH is defined as a large loss of blood within 24 hours of birth. If detected early enough, effective clinical management solutions exist that significantly reduce mortality. Current standard of care for detecting PPH rely on vital sign monitoring and visually inspecting the mother’s pad to estimate blood loss. However, visual inspection of pads is subjective and error prone while deterioration in vital signs are delayed indicators of maternal blood volume changes. Consequently, early and accurate detection of PPH remains a significant clinical challenge. Vasowatch LLC is developing an automated, continuous, and minimally burdensome monitoring system, called the Momitor, that can (1) accurately and rapidly identify symptoms of PPH and (2) deliver real-time and actionable clinical decision support linked to the identified PPH symptoms. The Momitor system will consist of a wearable device worn on an extremity consisting of LEDs, phototransistors, Wi-Fi radio, and battery. The non-invasive wearable will collect photoplethysmography (PPG) waveform data, run an algorithm that identifies the onset of waveform changes suggestive of PPH, and alert clinical staff to assess the mother through a cloud-based system with SMS and dashboard alerting capabilities. During PPH the body automatically diverts blood from non-vital extremities to vital organs as a lifesaving measure – which delays deterioration in vital signs. Consequently, rather than relying on error-prone visual inspection of sanitary pads and monitoring for delayed vital sign changes, the Momitor aims to screen for the mother’s automatic compensatory response consistent with PPH and hypovolemia. In this Phase I STTR, we will demonstrate proof-of- concept for detecting PPH before vital sign deterioration based on a modified compensatory reserve estimation by demonstrating an algorithm that can accurately detect PPH before existing standard of care, prototyping a wearable device that can collect and analyze PPG data for PPH from admission to 24-hours postpartum. Receipt of NIH funds will allow us to demonstrate proof-of-concept of the Momitor and provide sufficient evidence to pursue FDA Breakthrough Device designation. We believe this solution will address an urgent need and will broadly be appealing to hospitals, resulting in lower costs and greatly improved outcomes for patients – regardless of race. Expansion into non-hospital- based birth centers will follow.

抽象的： 产后出血（PPH）是全球孕产妇死亡的主要原因 PPH 对少数群体的影响尤为严重，其定义为 24 小时内大量失血。 如果足够早地发现，有效的临床管理解决方案可以显着减少出生时的风险。 目前检测 PPH 的护理标准依赖于生命体征监测和目视。 检查母亲的护垫来估计失血量 然而，护垫的目视检查是主观的。 并且容易出错，而生命体征恶化是母体血容量的延迟指标 经过测试，早期、准确地检测 PPH 仍然是一个重大的临床挑战。 Vasowatch LLC 正在开发一种自动化、连续且负担最小的监控系统 称为 Momitor 的系统，可以 (1) 准确、快速地识别 PPH 症状，以及 (2) 提供与已识别的 PPH 症状相关的实时且可操作的临床决策支持。 监控系统将由佩戴在四肢上的可穿戴设备组成，该设备由 LED 组成， 非侵入式可穿戴设备将收集光电晶体管、Wi-Fi 无线电和电池的信息。 光电体积描记法 (PPG) 波形数据，运行识别波形起始的算法 提示 PPH 的变化，并提醒临床工作人员通过基于云的系统评估母亲 具有短信和仪表板警报功能。在 PPH 期间，身体会自动转移血液。 将非生命体肢移植到重要器官作为救生措施，从而延缓生命体征恶化。 进行测试，而不是依靠容易出错的卫生巾目视检查和监测 由于生命体征变化延迟，Momitor 旨在筛查母亲的自动代偿性 与 PPH 和血容量不足的一致反应在第一阶段 STTR 中，我们将证明- 基于修正的代偿储备在生命体征恶化之前检测 PPH 的概念 通过演示一种可以在现有标准之前准确检测 PPH 的算法进行估计 护理，制作可穿戴设备原型，该设备可以收集和分析入院后 PPH 的 PPG 数据 产后 24 小时内收到 NIH 资金将使我们能够展示该项目的概念验证。 我们相信，监控并提供足够的证据来寻求 FDA 突破性器械认定。 该解决方案将解决紧迫需求，并将广泛吸引医院，从而降低 成本并大大改善患者的治疗效果——无论种族如何——扩展到非医院领域。 随后将设立基地生育中心。