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Completed

NCT Number: NCT02100865

Solar Powered Oxygen Delivery

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.

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Key information

Conditions

Pneumonia Hypoxemia Hypoxia Infections Lung Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jinja Regional Referral Hospital

Jinja, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solar powered oxygen

Device

Oxygen from cylinders

Device

Primary outcomes

  1. Length of hospital stay

    Time frame: Until end of hospitalization (usually 3 to 7 days)

    The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily.

Secondary outcomes

  1. Mortality

    Time frame: At hospital discharge (usually 3 to 7 days)

    In-hospital mortality will be quantified.

  2. Duration of supplemental oxygen therapy

    Time frame: Until hospital discharge (usually 3 to 7 days)

    Time to wean patient off oxygen. This is assessed daily using standard procedures.

  3. Proportion of patients successfully oxygenated

    Time frame: 6 hours

    Success defined as achieving a post-oxygen saturation above 90% within 6 hours.

  4. Oxygen delivery system failure

    Time frame: During hospitalization (usually 3 to 7 days)

    Failure defined as need for backup oxygen to maintain SpO2>90%.

  5. Cost

    Time frame: Until hospital discharge (usually 3 to 7 days)

    Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).

  6. Lambaréné Organ Dysfunction Score (LODS)

    Time frame: Until hospital discharge (usually 3 to 7 days)

    This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2014
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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