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Solar Powered Oxygen Delivery

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ClinicalTrials.gov Identifier: NCT02100865
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Pneumonia Hypoxemia Device: Solar powered oxygen Device: Oxygen from cylinders Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Solar powered oxygen
Solar panels used to drive an oxygen concentrator to deliver at stream of oxygen at approximately 90% FiO2 and a rate of 1-5L/min.
Device: Solar powered oxygen
Active Comparator: Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
Device: Oxygen from cylinders



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100865


Locations
Uganda
Jinja Regional Referral Hospital
Jinja, Uganda
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Michael T Hawkes, MD, PhD University of Alberta
Principal Investigator: Robert O Opoka, MBChB, MPH Makerere University

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02100865     History of Changes
Other Study ID Numbers: 0206-01
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Pneumonia
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Respiratory
Signs and Symptoms