Solar Oxygen Study

Pneumonia Clinical Trial

— SOS  

Official title:

Effect of Solar Powered Oxygen Delivery on Childhood Mortality in Uganda: A Cluster-Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851783
• Other study ID #: Pro00084784
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 20, 2021

Study information

• Verified date: February 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2405
• Est. completion date: December 20, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

1. Age under 5 years

2. Hypoxemia (SpO2<92%) based on non-invasive pulse oximetry

3. Hospital admission warranted based on clinician judgment

Exclusion Criteria:

1. SpO2 =92%

2. Outpatient management

3. Denial of consent to participate in study

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia
• Pneumonia

Intervention

Device:
• Solar-powered oxygen
Constant and reliable administration of oxygen, using solar panels to power an oxygen concentrator and deliver medical grade oxygen at 1-5L/min.

Locations

Country	Name	City	State
Uganda	Adumi Health Centre IV	Adumi
Uganda	Apac District Hospital	Apac
Uganda	Atiak Health Centre IV	Atiak
Uganda	Bugobero Health Centre IV	Bugobero
Uganda	Bukedea Health Centre IV	Bukedea
Uganda	Bumanya Health Centre IV	Bumanya
Uganda	Bundibugyo Hospital	Bundibugyo
Uganda	Kagadi Hospital	Kagadi
Uganda	Kalisizo Hospital	Kalisizo
Uganda	Kamuli General Hospital	Kamuli
Uganda	Kayunga District Hospital	Kayunga
Uganda	Kidera Health Centre IV	Kidera
Uganda	Kitagata Hospital	Kitagata
Uganda	Kitgum General Hospital	Kitgum
Uganda	Kyenjojo General Hospital	Kyenjojo
Uganda	Lalogi Health Centre IV	Lalogi
Uganda	Lyantonde Hospital	Lyantonde
Uganda	Gombe Hospital	Mpigi
Uganda	Muyembe Health Centre IV	Muyembe
Uganda	Sembabule Health Centre IV	Sembabule

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Global Health Uganda LTD

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

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. — View Citation

Turnbull H, Conroy A, Opoka RO, Namasopo S, Kain KC, Hawkes M. Solar-powered oxygen delivery: proof of concept. Int J Tuberc Lung Dis. 2016 May;20(5):696-703. doi: 10.5588/ijtld.15.0796. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality at 48 hours after admission	48 hours
Secondary	In hospital mortality	Mortality during any point of hospital admission	Until end of hospitalization (usually 3 to 7 days)
Secondary	Length of hospital stay	Total length of hospital admission	Until end of hospitalization (usually 3 to 7 days)
Secondary	Oxygen saturation	Measured oxygen saturations before and after administration of oxygen, using standard procedures	Until end of hospitalization (usually 3 to 7 days)
Secondary	Oxygen delivery system failure	Number and duration of failures in any component of the oxygen delivery system, including solar panels, batteries, oxygen concentrator, and electrical components	Until end of trial (24 months)
Secondary	Total costs of implementing solar-powered oxygen delivery systems	Total costs of implementing solar-powered oxygen delivery systems at twenty sites, including installation, servicing and maintenance	Until end of trial (24 months)