Development and implementation of pediatric mobile phone reflectance pulse oximeters and a hypoxemia surveillance system in South Africa

南非儿童手机反射式脉搏血氧计和低氧血症监测系统的开发和实施

• 批准号: 10880473
• 负责人: Eric Douglass McCollum
• 金额: $ 28.16万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-10 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10880473
• 关键词: 2019-nCoV; 5 year old; Address; Adult; Affect; Africa; Africa South of the Sahara; African; Asia; Award; Breathing; COVID-19; COVID-19 treatment; Caregivers; Caring; Cause of Death; Cellular Phone; Cessation of life; Child; Child health care; Childhood; Clinic; Clinical; Communities; Country; Dehydration; Development; Developmental Process; Devices; Diagnosis; Diagnostic; Disease; Ecosystem; Ensure; Fingers; Focus Groups; Goals; Health; Health Services; Health Services Accessibility; Health system; High Prevalence; Hypoxemia; Income; Interview; Laboratories; Language; Life; Low income; Lower Respiratory Tract Infection; Measurement; Measures; Morphologic artifacts; Motion; Outcome; Oxygen; Oxyhemoglobin; Pathway interactions; Performance; Peripheral; Phase; Physiologic pulse; Prevalence; Primary Health Care; Process; Questionnaires; Randomized, Controlled Trials; Research; Respiratory Disease; Rural Community; South Africa; South African; Standardization; Surface; System; Technology; Testing; Theory of Change; Thinking; Time; Toes; United States National Institutes of Health; Work; acceptability and feasibility; blood perfusion; cost; design; eHealth; electronic health system; experimental study; field study; human centered design; ideation; implementation evaluation; implementation fidelity; implementation outcomes; improved; improved outcome; innovation; interoperability; mortality; mortality risk; multidisciplinary; noninvasive diagnosis; pandemic disease; peripheral blood; primary outcome; product development; prototype; response; scale up; secondary outcome; signal processing; success; treatment center; viral pandemic

PROJECT SUMMARY: This is a submission for a National Institutes of Health R21/R33 award aiming to develop and validate a context-appropriate, inexpensive mobile phone-based pediatric reflectance pulse oximeter compatible with an interoperable hypoxemia surveillance system (R21 period), and then to evaluate the field implementation of a mobile phone reflectance pulse oximeter and hypoxemia eHealth system using a cluster, randomized controlled trial (R33 period). Lower respiratory infections (LRIs) are the leading infectious cause of death globally among children below five years of age in low-income and middle-income countries (LMICs). Hypoxemia, a low oxyhemoglobin saturation, is a key indicator of elevated LRI mortality risk. Pulse oximeters are devices that non-invasively measure the peripheral oxyhemoglobin saturation (SpO2) to identify hypoxemia, but are not widely available in LMICs for children, especially at primary healthcare clinics where children first access care. Although oxygen is potentially a life-saving treatment for hypoxemic LRIs, health systems in LMICs do not have well established oxygen systems to appropriately match supply with demand to optimally benefit children. We aim to develop, validate, and rigorously evaluate the implementation of an innovative, inexpensive mobile phone-based reflectance pulse oximeter, embedded within an electronic health DHIS2 platform for real- time hypoxemia diagnosis and surveillance of children in LMICs. We hypothesize that the pulse oximeter's performance will be valid and that its implementation within a DHIS2 electronic health platform will address key implementation endpoints in a conceptual framework and theory of change construct for improving pediatric LRI mortality in LMICs. To accomplish our overall project goal we will build upon our prior successful pediatric pulse oximeter development work in sub-Saharan Africa and South Asia using an innovative, multidisciplinary product development process called human centered design. During the two-year R21 period we will apply the human centered design approach to develop a mobile phone-based reflectance pulse oximeter and eHealth system (Aim 1). The device will be validated in a breath-down laboratory and field tested in various clinical settings with a range of practitioners in Cape Town, South Africa. We will then implement the pulse oximeter and DHIS2 system within a large township in Cape Town, South Africa and conduct a cluster, randomized controlled trial to evaluate implementation fidelity as the primary outcome (Aim 2), as well as secondary outcomes of implementation acceptability and feasibility. Successful completion of the research described in this application could lead to broader scale-up of an affordable, sustainable interoperable hypoxemia eHealth system with advanced but accessible mobile phone technology contextually appropriate for LMICs, where most pediatric deaths from hypoxemic LRIs occur.

项目摘要： 这是国立卫生研究院R21/R33奖的提交，旨在开发和验证 适合上下文，廉价的基于手机的小儿反射率脉搏血氧仪与 互操作性低氧监测系统（R21时期），然后评估现场实施 手机反射率脉搏血氧仪和低氧血症eHealth系统使用集群，随机 对照试验（R33时期）。下呼吸道感染（LRI）是主要的感染原因 在低收入和中等收入国家（LMIC）的五岁以下儿童中，全球范围内。 低氧血红蛋白饱和度低氧血症是LRI死亡率升高的关键指标。脉搏血氧仪 是非侵入性测量外周的氧气血红蛋白饱和度（SPO2）的设备以识别 低氧血症，但在儿童的LMIC中并不广泛，尤其是在初级医疗保健诊所 儿童首先获得护理。尽管氧气可能是低氧LRI的生命疗法，但健康 LMIC中的系统没有建立的氧气系统，无法适当地匹配供应与需求 最佳儿童受益。 我们旨在开发，验证和严格评估创新，廉价的实施 基于移动电话的反射率脉搏血氧仪，嵌入了电子健康DHIS2平台中，用于实现 LMICS儿童的时间低氧诊断和监测。我们假设脉搏血氧仪的 性能将是有效的，并且其在DHIS2电子健康平台中的实施将解决密钥 在改善小儿的概念框架和变革构建理论中的实施终点 LMIC中的LRI死亡率。为了实现我们的整体项目目标，我们将基于先前的成功儿科 撒哈拉以南非洲和南亚的脉搏血氧仪开发工作使用创新的多学科 产品开发过程称为人类以人为中心的设计。在两年R21期间，我们将申请 以人为中心的设计方法开发基于手机的反射率脉搏血氧仪和eHealth 系统（目标1）。该设备将在呼吸的实验室和现场进行验证，并在各种临床上测试 与南非开普敦的一系列从业人员的设置。然后，我们将实施脉搏血氧仪 和DHIS2系统在南非开普敦的一个大乡镇内，并进行了一个随机的集群 对照试验评估实施保真度为主要结果（AIM 2）以及次要 实施可接受性和可行性的结果。 成功完成本申请中描述的研究可能会导致更广泛的规模扩大 负担得起的可持续可互操作缺氧性eHealth系统，具有先进但易于使用的手机 在上下文上，适用于LMIC的技术，大多数患有低氧LRI的儿科死亡。