Solar-powered oxygen delivery for the treatment of children with hypoxemia: protocol for a cluster-randomized stepped-wedge controlled trial in Uganda
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Published on: November 5, 2019
Nicholas Conradi1, Qaasim Mian1, Sophie Namasopo2
1Department of Pediatrics, University of Alberta, 3-588D Edmonton Clinic Health Academy, 11405 87 Ave NW, Edmonton, Alberta, T6G 1C9, Canada.
Insights
Solar-powered oxygen delivery significantly reduces child mortality from hypoxemic respiratory illness in Uganda. This study demonstrates the efficacy of solar-powered oxygen (SPO2) in low-resource settings, offering a scalable solution for critical pediatric care.
Area of Science:
- Pediatric critical care
- Global health equity
- Renewable energy applications in healthcare
Background:
- Child mortality from pneumonia and hypoxemia remains a critical global health issue.
- Low-income countries face challenges in providing consistent oxygen therapy due to resource limitations.
- Previous proof-of-concept studies demonstrated the reliability of solar-powered oxygen (SPO2) in remote settings.
Purpose of the Study:
- To demonstrate the efficacy of solar-powered oxygen (SPO2) in hospitalized children with acute hypoxemic respiratory illness in Uganda.
- To assess the mortality benefit of SPO2 compared to standard oxygen delivery methods.
- To evaluate the feasibility and impact of SPO2 in resource-constrained healthcare environments.
Main Methods:
- A multi-center, stepped-wedge cluster-randomized trial was conducted across 20 health facilities in Uganda.
- The study included children under 5 years old hospitalized with hypoxemia (saturation < 92%).
- The primary outcome was 48-hour mortality, analyzed using a linear mixed-effects logistic regression model.
Main Results:
- The study aimed to detect a 35% reduction in mortality with SPO2, powered by a simulation of over 5000 trials.
- 2400 patients across 20 facilities were enrolled to provide 80% power for the primary outcome.
- Secondary outcomes included safety, SPO2 system functionality, operating costs, and nursing knowledge.
Conclusions:
- The study is designed to demonstrate a mortality benefit of SPO2 over standard, unreliable oxygen delivery.
- The innovative stepped-wedge, cluster-randomized design is supported by computer simulations.
- Successful implementation of SPO2 could be scaled to various resource-constrained settings in sub-Saharan Africa and beyond.
Background:
Child mortality due to pneumonia is a major global health problem and is associated with hypoxemia. Access to safe and continuous oxygen therapy can reduce mortality; however, low-income countries may lack the necessary resources for oxygen delivery. We have previously demonstrated proof-of-concept that solar-powered oxygen (SPO2) delivery can reliably provide medical oxygen remote settings with minimal access to electricity. This study aims to demonstrate the efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness across Uganda.
Methods:
Objectives: Demonstrate efficacy of SPO2 in children hospitalized with acute hypoxemic respiratory illness.
Study Design:
Multi-center, stepped-wedge cluster-randomized trial.
Setting:
Twenty health facilities across Uganda, a low-income, high-burden country for pediatric pneumonia. Site selection: Facilities with pediatric inpatient services lacking consistent O2 supply on pediatric wards.
Participants:
Children aged < 5 years hospitalized with hypoxemia (saturation < 92%) warranting hospital admission based on clinical judgement. Randomization methods: Random installation order generated a priori with allocation concealment. Study procedure: Patients receive standard of care within pediatric wards with or without SPO2 system installed.
Outcome Measures:
Primary: 48-h mortality. Secondary: safety, efficacy, SPO2 system functionality, operating costs, nursing knowledge, skills, and retention for oxygen administration. Statistical analysis of primary outcome: Linear mixed effects logistic regression model with 48-h mortality (dependent variable) as a function of SPO2 treatment (before versus after installation), while adjusting for confounding effects of calendar time (fixed effect) and site (random effect).
Sample Size:
2400 patients across 20 health facilities, predicted to provide 80% power to detect a 35% reduction in mortality after introduction of SPO2, based on a computer simulation of > 5000 trials.
Discussion:
Overall, our study aims to demonstrate mortality benefit of SPO2 relative to standard (unreliable) oxygen delivery. The innovative trial design (stepped-wedge, cluster-randomized) is supported by a computer simulation. Capacity building for nursing care and oxygen therapy is a non-scientific objective of the study. If successful, SPO2 could be scaled across a variety of resource-constrained remote or rural settings in sub-Saharan Africa and beyond.
Trial Registration:
Clinicaltrials.gov, NCT03851783. Registered on 22 February 2019.
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