Clinical trial NCT02100865: Solar Powered Oxygen Delivery
Official title: Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Hypoxemia
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 130
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Until end of hospitalization (usually 3 to 7 days)
Secondary outcomes:
measure: Mortality
timeFrame: At hospital discharge (usually 3 to 7 days)
measure: Duration of supplemental oxygen therapy
timeFrame: Until hospital discharge (usually 3 to 7 days)
measure: Proportion of patients successfully oxygenated
timeFrame: 6 hours
measure: Oxygen delivery system failure
timeFrame: During hospitalization (usually 3 to 7 days)
measure: Cost
timeFrame: Until hospital discharge (usually 3 to 7 days)
measure: Lambaréné Organ Dysfunction Score (LODS)
timeFrame: Until hospital discharge (usually 3 to 7 days)
Other outcomes:
Locations:
city: Jinja
country: Uganda
facility: Jinja Regional Referral Hospital
Study officials:
affiliation: University of Alberta
name: Michael T Hawkes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Robert O Opoka, MBChB, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.