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.

摘要： 产后出血(PPH)是全世界孕产妇死亡的主要原因， 对少数群体的影响不成比例。产后出血定义为24小时内失血过多。 出生地。如果及早发现，存在有效的临床管理解决方案，可以显著减少 死亡率。目前检测PPH的护理标准依赖于生命体征监测和视觉 检查母亲的垫子以估计失血量。然而，焊盘的目测检查是主观的 在生命体征恶化的情况下，母体血量的延迟指标容易出错 改变。因此，早期和准确地检测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 一种名为Momvisor的系统，可以(1)准确快速地识别PPH的症状和(2) 提供与已识别的PPH症状相关联的实时、可操作的临床决策支持。这个 监控系统将由戴在由LED组成的四肢上的可穿戴设备组成， 光电晶体管、Wi-Fi收音机和电池。非侵入式可穿戴设备将收集 光体积描记(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 具有短信和仪表板提醒功能。在PPH期间，身体会自动将血液从 将非生命的四肢连接到重要器官，这是一种挽救生命的措施，可以延缓生命体征的恶化。 因此，不是依赖于容易出错的卫生巾的视觉检查和监控 延缓生命体征变化，监督员旨在筛查母亲的自动代偿 反应与产后出血和低血容量一致。在本阶段1中，我们将演示 基于修正代偿储备的生命体征恶化前PPH检测概念 通过演示一种算法进行估计，该算法可以在现有标准之前准确检测PPH CARE，制作一款可穿戴设备的原型，可以从入院时收集和分析PPH的PPG数据 到产后24小时。收到NIH的资金将使我们能够展示 并提供足够的证据，以寻求FDA突破性设备的指定。我们相信 这一解决方案将解决紧急需求，并将广泛吸引医院，从而降低 成本和极大地改善了患者的结果--不分种族。扩展到非医院- 以出生为基础的中心将紧随其后。