Solar Powered Oxygen Delivery

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100865
• Other study ID #: 0206-01
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2014
• Last updated: September 14, 2016
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 13 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anoxia
• Hypoxemia
• Pneumonia

Intervention

Device:
• Solar powered oxygen

• Oxygen from cylinders

Locations

Country	Name	City	State
Uganda	Jinja Regional Referral Hospital	Jinja

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	The number of days from admission to discharge. Criteria for discharge are standardized and are assessed daily.	Until end of hospitalization (usually 3 to 7 days)	No
Secondary	Mortality	In-hospital mortality will be quantified.	At hospital discharge (usually 3 to 7 days)	Yes
Secondary	Duration of supplemental oxygen therapy	Time to wean patient off oxygen. This is assessed daily using standard procedures.	Until hospital discharge (usually 3 to 7 days)	No
Secondary	Proportion of patients successfully oxygenated	Success defined as achieving a post-oxygen saturation above 90% within 6 hours.	6 hours	Yes
Secondary	Oxygen delivery system failure	Failure defined as need for backup oxygen to maintain SpO2>90%.	During hospitalization (usually 3 to 7 days)	Yes
Secondary	Cost	Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).	Until hospital discharge (usually 3 to 7 days)	No
Secondary	Lambaréné Organ Dysfunction Score (LODS)	This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.	Until hospital discharge (usually 3 to 7 days)	Yes

External Links

•   Global Health Uganda is the non-governmental organization (NGO) partner in Uganda