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: 10471937
• 负责人: Eric Douglass McCollum
• 金额: $ 20.71万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10471937
• 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; Car Phone; Caregivers; Caring; Cause of Death; 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; Lead; 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; Savings; South Africa; South African; Standardization; Surface; System; Technology; Testing; Theory of Change; Thinking; Time; Toes; Triad Acrylic Resin; United States National Institutes of Health; Viral; Work; acceptability and feasibility; base; blood perfusion; cost; design; 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

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.

项目概要： 这是美国国立卫生研究院 R21/R33 奖项的提交，旨在开发和验证 适合具体情况的、廉价的基于移动电话的儿科反射脉搏血氧计，与 可互操作的低氧血症监测系统（R21时期），然后评估现场实施情况 使用集群、随机的手机反射式脉搏血氧仪和低氧血症电子医疗系统 对照试验（R33期）。下呼吸道感染（LRI）是导致死亡的主要原因 全球范围内低收入和中等收入国家（LMIC）五岁以下儿童。 低氧血症（一种低氧合血红蛋白饱和度）是 LRI 死亡风险升高的关键指标。脉搏血氧计 是非侵入性测量外周氧合血红蛋白饱和度 (SpO2) 的设备，以识别 低氧血症，但在中低收入国家儿童中并未广泛提供，特别是在初级保健诊所， 儿童首先获得护理。尽管吸氧可能是治疗低氧 LRI 的一种挽救生命的方法，但健康 中低收入国家的系统没有完善的氧气系统来适当匹配供应和需求 最有利于儿童。 我们的目标是开发、验证和严格评估创新、廉价的实施 基于移动电话的反射式脉搏血氧计，嵌入电子健康DHIS2平台中，用于实时 中低收入国家儿童低氧血症的及时诊断和监测。我们假设脉搏血氧仪的 性能将是有效的，并且其在 DHIS2 电子健康平台内的实施将解决关键问题 改善儿科的概念框架和变革理论的实施终点 中低收入国家的 LRI 死亡率。为了实现我们的总体项目目标，我们将以之前成功的儿科项目为基础 使用创新的多学科技术在撒哈拉以南非洲和南亚开展脉搏血氧计开发工作 产品开发过程称为以人为本的设计。在两年的 R21 期间，我们将应用 以人为本的设计方法开发基于手机的反射式脉搏血氧计和电子医疗 系统（目标 1）。该设备将在严格的实验室中进行验证，并在各种临床中进行现场测试 南非开普敦的一系列从业者的环境。然后我们将实施脉搏血氧计 和 DHIS2 系统在南非开普敦的一个大城镇内进行集群、随机 对照试验评估实施保真度作为主要结果（目标 2），以及次要结果 实施结果的可接受性和可行性。 成功完成本申请中描述的研究可能会导致更广泛的规模化 负担得起的、可持续的、可互操作的低氧血症电子医疗系统，配备先进且易于使用的移动电话 该技术适合中低收入国家，大多数儿童因低氧血症而死亡。