Solar Powered Oxygen Delivery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders

Conditions
-----------------
Pneumonia, Hypoxemia

Intervention / Treatment
-----------------
* Device: Solar powered oxygen
* Device: Oxygen from cylinders


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solar powered oxygen<br>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<br> <br> |
| Active Comparator: Oxygen from cylinders<br>Conventional oxygen delivery from compressed gas cylinders | Device: Oxygen from cylinders<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily. | Until end of hospitalization (usually 3 to 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In-hospital mortality will be quantified. | At hospital discharge (usually 3 to 7 days) | 
| Duration of supplemental oxygen therapy | Time to wean patient off oxygen. This is assessed daily using standard procedures. | Until hospital discharge (usually 3 to 7 days) | 
| Proportion of patients successfully oxygenated | Success defined as achieving a post-oxygen saturation above 90% within 6 hours. | 6 hours | 
| Oxygen delivery system failure | Failure defined as need for backup oxygen to maintain SpO2>90%. | During hospitalization (usually 3 to 7 days) | 
| Cost | Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm). | Until hospital discharge (usually 3 to 7 days) | 
| Lambaréné Organ Dysfunction Score (LODS) | This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia. | Until hospital discharge (usually 3 to 7 days) |