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）是全球孕产妇死亡的主要原因， 对少数群体的影响尤为严重。PPH的定义是24小时内大量失血 出生。如果发现得足够早，有效的临床管理解决方案可以显著减少 mortality.目前用于检测PPH的护理标准依赖于生命体征监测和视觉检查。 检查母亲的子宫垫估计失血量然而，垫的目视检查是主观的 并且容易出错，而生命体征的恶化是母体血容量的延迟指标 变化因此，PPH的早期和准确检测仍然是一个重大的临床挑战。 Vasowatch LLC正在开发一种自动化，连续和最小负担的监测 系统，称为Momitor，可以（1）准确和快速地识别PPH的症状和（2） 提供与所识别的PPH症状相关的实时和可操作的临床决策支持。的 Momitor系统将由穿戴在肢体上的可穿戴设备组成，包括LED， 光电晶体管、Wi-Fi无线电和电池。这种非侵入性的可穿戴设备将收集 光电体积描记（PPG）波形数据，运行识别波形的开始的算法， 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 短信和仪表板报警功能。在PPH过程中，身体会自动将血液从 将非重要肢体转移到重要器官作为一种救生措施--这可延缓生命体征的恶化。 因此，不是依赖于容易出错的卫生护垫的视觉检查和对卫生护垫的性能的监测， 延迟的生命体征变化，Momitor旨在筛查母亲的自动代偿性 反应与PPH和低血容量一致。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 通过演示一种算法来估计，该算法可以在现有标准之前准确检测PPH。 护理，原型设计可穿戴设备，可以从入院开始收集和分析PPH的PPG数据 到产后24小时。接受NIH的资金将使我们能够证明 Momitor并提供充分的证据以获得FDA突破性器械认定。我们认为 这一解决方案将解决迫切的需求，并将广泛吸引医院，从而降低 成本和大大改善患者的结果-无论种族如何。扩展到非医院- 生育中心将继续。