Solar Powered Oxygen Delivery
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
研究概览
详细说明
Arterial hypoxemia in pneumonia results from several mechanisms: pulmonary arterial blood flow to consolidated lung resulting in an intrapulmonary shunt, intrapulmonary oxygen consumption, and ventilation-perfusion mismatch. Hypoxemia is a risk factor for mortality in pediatric pneumonia, and was associated with a 5-fold increased risk of death in studies from Kenya and Gambia.
In one report from Nepal, the prevalence of hypoxemia (SpO2 < 90%) in 150 children with pneumonia was 39% overall, with increasing rates of hypoxemia across strata of pneumonia severity (100% of very severe, 80% of severe and 17% of pneumonia patients). General features of respiratory distress were associated with hypoxemia in this study, including chest indrawing, lethargy, grunting, nasal flaring, cyanosis, inability to breastfeed or drink.
Few studies have reported on the use of solar powered oxygen (SPO2) delivery. One online report describes the use of a battery-powered oxygenator in the Gambia that could be adapted to use solar power (http://www.dulas.org.uk). Otherwise, our intervention is to our knowledge the first example of SPO2 delivery.
New ways to deliver oxygen for children with pneumonia in Africa could improve outcomes and save numerous lives. If this study documents the non-inferiority of SPO2 relative to standard oxygen delivery, this novel method of providing life-saving oxygen could be rolled out across centres in sub-Saharan Africa where oxygen cylinders are not widely available and electrical power is not reliable. The potential energy efficiency, low cost and ease of use make solar power an attractive avenue of investigation for use in resource-constrained settings. Proof-of-concept that the sun can be used to drive oxygen delivery could stimulate commercial interest in this technology. The SPO2 system could thus achieve rapid penetration into the most remote or rural settings in sub-Saharan Africa.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Jinja、乌干达
- Jinja Regional Referral Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age <13 years
- IMCI defined pneumonia, severe pneumonia or very severe disease
- Hypoxemia (SpO2<90%) based on non-invasive pulse oximetry
- Hospital admission warranted based on clinician judgment
- Consent to blood sampling and data collection
Exclusion Criteria:
- SpO2 ≥90%
- Suspected pulmonary tuberculosis
- Outpatient management
- Denial of consent to participate in study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Solar powered oxygen
Solar panels used to drive an oxygen concentrator to deliver at stream of oxygen at approximately 90% FiO2 and a rate of 1-5L/min.
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有源比较器:Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Length of hospital stay
大体时间:Until end of hospitalization (usually 3 to 7 days)
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The number of days from admission to discharge.
Criteria for discharge are standardized and are assessed daily.
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Until end of hospitalization (usually 3 to 7 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mortality
大体时间:At hospital discharge (usually 3 to 7 days)
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In-hospital mortality will be quantified.
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At hospital discharge (usually 3 to 7 days)
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Duration of supplemental oxygen therapy
大体时间:Until hospital discharge (usually 3 to 7 days)
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Time to wean patient off oxygen.
This is assessed daily using standard procedures.
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Until hospital discharge (usually 3 to 7 days)
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Proportion of patients successfully oxygenated
大体时间:6 hours
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Success defined as achieving a post-oxygen saturation above 90% within 6 hours.
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6 hours
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Oxygen delivery system failure
大体时间:During hospitalization (usually 3 to 7 days)
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Failure defined as need for backup oxygen to maintain SpO2>90%.
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During hospitalization (usually 3 to 7 days)
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Cost
大体时间:Until hospital discharge (usually 3 to 7 days)
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Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).
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Until hospital discharge (usually 3 to 7 days)
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Lambaréné Organ Dysfunction Score (LODS)
大体时间:Until hospital discharge (usually 3 to 7 days)
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This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.
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Until hospital discharge (usually 3 to 7 days)
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合作者和调查者
调查人员
- 首席研究员:Michael T Hawkes, MD, PhD、University of Alberta
- 首席研究员:Robert O Opoka, MBChB, MPH、Makerere University
出版物和有用的链接
一般刊物
- Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, Peel D. Improved oxygen systems for childhood pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet. 2008 Oct 11;372(9646):1328-33. doi: 10.1016/S0140-6736(08)61164-2. Epub 2008 Aug 15.
- Hawkes MT, Conroy AL, Namasopo S, Bhargava R, Kain KC, Mian Q, Opoka RO. Solar-Powered Oxygen Delivery in Low-Resource Settings: A Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2018 Jul 1;172(7):694-696. doi: 10.1001/jamapediatrics.2018.0228.
- Nyende S, Conroy A, Opoka RO, Namasopo S, Kain KC, Mpimbaza A, Bhargava R, Hawkes M. Solar-powered oxygen delivery: study protocol for a randomized controlled trial. Trials. 2015 Jul 9;16:297. doi: 10.1186/s13063-015-0814-y.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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