Solar Powered Oxygen Delivery
Primary Purpose
Pneumonia, Hypoxemia
Status
Completed
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
Solar powered oxygen
Oxygen from cylinders
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia
Eligibility 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
Sites / Locations
- Jinja Regional Referral Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Solar powered oxygen
Oxygen from cylinders
Arm Description
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.
Conventional oxygen delivery from compressed gas cylinders
Outcomes
Primary Outcome Measures
Length of hospital stay
The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily.
Secondary Outcome Measures
Mortality
In-hospital mortality will be quantified.
Duration of supplemental oxygen therapy
Time to wean patient off oxygen. This is assessed daily using standard procedures.
Proportion of patients successfully oxygenated
Success defined as achieving a post-oxygen saturation above 90% within 6 hours.
Oxygen delivery system failure
Failure defined as need for backup oxygen to maintain SpO2>90%.
Cost
Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).
Lambaréné Organ Dysfunction Score (LODS)
This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.
Full Information
NCT ID
NCT02100865
First Posted
March 27, 2014
Last Updated
September 14, 2016
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02100865
Brief Title
Solar Powered Oxygen Delivery
Official Title
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Hypoxemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Solar powered oxygen
Arm Type
Experimental
Arm Description
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.
Arm Title
Oxygen from cylinders
Arm Type
Active Comparator
Arm Description
Conventional oxygen delivery from compressed gas cylinders
Intervention Type
Device
Intervention Name(s)
Solar powered oxygen
Intervention Type
Device
Intervention Name(s)
Oxygen from cylinders
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily.
Time Frame
Until end of hospitalization (usually 3 to 7 days)
Secondary Outcome Measure Information:
Title
Mortality
Description
In-hospital mortality will be quantified.
Time Frame
At hospital discharge (usually 3 to 7 days)
Title
Duration of supplemental oxygen therapy
Description
Time to wean patient off oxygen. This is assessed daily using standard procedures.
Time Frame
Until hospital discharge (usually 3 to 7 days)
Title
Proportion of patients successfully oxygenated
Description
Success defined as achieving a post-oxygen saturation above 90% within 6 hours.
Time Frame
6 hours
Title
Oxygen delivery system failure
Description
Failure defined as need for backup oxygen to maintain SpO2>90%.
Time Frame
During hospitalization (usually 3 to 7 days)
Title
Cost
Description
Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).
Time Frame
Until hospital discharge (usually 3 to 7 days)
Title
Lambaréné Organ Dysfunction Score (LODS)
Description
This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.
Time Frame
Until hospital discharge (usually 3 to 7 days)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T Hawkes, MD, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert O Opoka, MBChB, MPH
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinja Regional Referral Hospital
City
Jinja
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
18708248
Citation
Duke T, Wandi F, Jonathan M, Matai S, Kaupa M, Saavu M, Subhi R, Peel D. Improved oxygen systems for childhood pneumonia: a multihospital effectiveness study in Papua New Guinea. Lancet. 2008 Oct 11;372(9646):1328-33. doi: 10.1016/S0140-6736(08)61164-2. Epub 2008 Aug 15.
Results Reference
result
PubMed Identifier
29800014
Citation
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.
Results Reference
derived
PubMed Identifier
26156116
Citation
Nyende S, Conroy A, Opoka RO, Namasopo S, Kain KC, Mpimbaza A, Bhargava R, Hawkes M. Solar-powered oxygen delivery: study protocol for a randomized controlled trial. Trials. 2015 Jul 9;16:297. doi: 10.1186/s13063-015-0814-y.
Results Reference
derived
Links:
URL
http://globalhealthuganda.org/
Description
Global Health Uganda is the non-governmental organization (NGO) partner in Uganda
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