Solar Powered Oxygen Delivery
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|ClinicalTrials.gov Identifier: NCT02100865|
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : September 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Hypoxemia||Device: Solar powered oxygen Device: Oxygen from cylinders||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: 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.
Device: Solar powered oxygen
Active Comparator: Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
Device: Oxygen from cylinders
- Length of hospital stay [ Time Frame: Until end of hospitalization (usually 3 to 7 days) ]The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily.
- Mortality [ Time Frame: At hospital discharge (usually 3 to 7 days) ]In-hospital mortality will be quantified.
- Duration of supplemental oxygen therapy [ Time Frame: Until hospital discharge (usually 3 to 7 days) ]Time to wean patient off oxygen. This is assessed daily using standard procedures.
- Proportion of patients successfully oxygenated [ Time Frame: 6 hours ]Success defined as achieving a post-oxygen saturation above 90% within 6 hours.
- Oxygen delivery system failure [ Time Frame: During hospitalization (usually 3 to 7 days) ]Failure defined as need for backup oxygen to maintain SpO2>90%.
- Cost [ Time Frame: Until hospital discharge (usually 3 to 7 days) ]Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).
- Lambaréné Organ Dysfunction Score (LODS) [ Time Frame: Until hospital discharge (usually 3 to 7 days) ]This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100865
|Jinja Regional Referral Hospital|
|Principal Investigator:||Michael T Hawkes, MD, PhD||University of Alberta|
|Principal Investigator:||Robert O Opoka, MBChB, MPH||Makerere University|