Pneumonia Clinical Trial
Official title:
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
Globally, approximately 2.1 million children die of pneumonia each year. Most deaths occur in resource-poor settings in Africa and Asia. Oxygen (O2) therapy is essential to support life in these patients. Large gaps remain in the case management of children presenting to African hospitals with respiratory distress, including essential supportive therapies such as supplemental oxygen. We hypothesize that a novel strategy for oxygen delivery, solar-powered oxygen, can be implemented in remote locations and will be non-inferior to standard oxygen delivery by compressed gas cylinders.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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