Solar Oxygen Study
Condition: Pneumonia; Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Globally, approximately 7.7 million children per year die before the age of 5 years.
      Infectious diseases account for a large proportion of these deaths, with pneumonia being the
      leading cause of mortality (2.1 million deaths/year). Most deaths occur in resource-poor
      settings in Asia and Africa. 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. In resource-constrained settings, oxygen delivery systems can lead to
      measurable improvements in survival from childhood pneumonia. A multihospital effectiveness
      study in Papua New Guinea demonstrated a reduction in mortality from childhood pneumonia from
      5.0% to 3.2% (35% reduction in mortality) after implementation of enhanced oxygen delivery
      system. The investigators propose to investigate a novel strategy for oxygen delivery that
      could be implemented in remote locations with minimal access to an electrical power supply:
      solar-powered oxygen (SPO2).
    

Detailed description: 
      Clinical features of pneumonia in children include fever, respiratory distress, and
      hypoxemia. Respiratory distress is a useful clinical summary description with good
      inter-observer consistency among experienced medical practitioners. The following clinical
      signs may indicate increased work of breathing: sustained nasal flaring; indrawing
      (recession) of the bony structures of the chest wall (subcostal, intercostal,
      supraclavicular) on inspiration; tracheal tug; and deep breathing (acidotic or Kussmaul
      breathing). Respiratory distress is a sign that one or more serious pathological processes
      are at play: metabolic acidosis, fluid overload, acute lung injury, and/or co-morbid
      pneumonitis. Respiratory distress, together with alteration of consciousness, is a strong
      predictor of mortality in children with severe febrile illness in sub-Saharan Africa. The
      grim prognostic significance of respiratory distress applies to several disease states,
      irrespective of microbial etiology, including malaria as well as non-malaria febrile illness.

      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.

      Oxygen is a lifesaving therapy for children with pneumonia and hypoxemia; however, challenges
      remain in oxygen delivery globally. Two main systems of oxygen delivery have been implemented
      and evaluated in resource-constrained settings, oxygen cylinders and oxygen concentrators.
      Oxygen cylinders are ready to use, simple to operate and do not require any electricity.
      However, cylinders are very costly and distribution and use is challenging. Oxygen
      concentrators have proven to be an effective means of delivering oxygen and are significantly
      less expensive that cylinders. However, oxygen concentrators require continuous and reliable
      electricity to operate which is not readily available in many regions, particularly in
      resource-limited settings where the majority of pneumonia deaths occur. In order to meet the
      demand for oxygen therapy in resource-limited settings, the investigators developed a novel
      strategy for oxygen delivery: solar-powered oxygen (SPO2). This system uses free inputs (sun
      and air) and could be implemented in remote locations with minimal access to an electrical
      power supply. Our group is the first to conduct rigorous scientific trials of SPO2.

      To date, the investigators have accumulated substantial clinical experience with SPO2, having
      treated >150 hypoxemic children, over several years, at two Ugandan hospitals. Compared to
      other oxygen delivery methods, SPO2 is superior. SPO2 is more reliable than oxygen
      concentrators connected to grid electricity, because it is not affected by frequent power
      outages. SPO2 utilizes a renewable, sustainable and freely available source of energy. SPO2
      is more reliable than compressed oxygen cylinders, which are frequently out of stock in the
      public hospital system. SPO2 is more user-friendly and safer for nurses than cylinders, which
      require physical strength to change regulators on high-pressure cylinders. SPO2 is less
      wasteful than cylinders, which tend to leak through ill-fitting regulators under real-world
      conditions.

      The study is a multi-centre prospective evaluation of SPO2. The investigators will use a
      stepped-wedge cluster-randomized design to allow for robust scientific conclusions about the
      efficacy of SPO2. Importantly, demonstration of a mortality benefit of SPO2 will provide
      strong supportive evidence and could catalyse the widespread implementation of SPO2 in
      resource-limited settings across Africa and Asia.
    

Intervention name(s): Solar-powered oxygen
Intervention type(s): Device
Intervention description(s): Constant and reliable administration of oxygen, using solar panels to power an oxygen concentrator and deliver medical grade oxygen at 1-5L/min.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Stepped-wedge cluster randomized controlled trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solar; oxygen