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PneumoniaPhase 2NCT02100865

Solar Powered Oxygen Delivery

A Phase 2 study testing Solar powered oxygen and Oxygen from cylinders in people with Pneumonia and Hypoxemia, run by University of Alberta at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 13 years
Conditions the study is for
Pneumonia, Hypoxemia
What is being tested?
Solar powered oxygen and Oxygen from cylinders
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteUganda
Study dates
Feb 2014to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • SpO2 ≥90%
  • Suspected pulmonary tuberculosis
  • Outpatient management
  • Denial of consent to participate in study

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Jinja Regional Referral Hospital

    Jinja

Other trials in Uganda

About this study

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

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.

Read the 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.

Conditions
Pneumonia, Hypoxemia
Being tested
Solar powered oxygen, Oxygen from cylinders
Medical subject headings
Pneumonia, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solar powered oxygenDevice

  • Oxygen from cylindersDevice

Study groups in NCT02100865
Study groupRoleWhat they receive
Solar powered oxygenExperimentalSolar panels used to drive an oxygen concentrator to deliver at stream of oxygen at approximately 90% FiO2 and a rate of 1-5L/min.
Receives: Device: Solar powered oxygen
Oxygen from cylindersActive comparatorConventional oxygen delivery from compressed gas cylinders
Receives: Device: Oxygen from cylinders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of hospital stay

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

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

Secondary outcomes (6)

  1. Mortality

    In-hospital mortality will be quantified.

    Measured: At hospital discharge (usually 3 to 7 days)

  2. Duration of supplemental oxygen therapy

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

    Measured: Until hospital discharge (usually 3 to 7 days)

  3. Proportion of patients successfully oxygenated

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

    Measured: 6 hours

  4. Oxygen delivery system failure

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

    Measured: During hospitalization (usually 3 to 7 days)

  5. Cost

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

    Measured: Until hospital discharge (usually 3 to 7 days)

  6. Lambaréné Organ Dysfunction Score (LODS)

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

    Measured: Until hospital discharge (usually 3 to 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02100865
Sponsor's protocol ID
0206-01
Status last verified
Sep 2016
First submitted
27 Mar 2014
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18708248

  • 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.

    PubMed 29800014

  • 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.

    PubMed 26156116

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Solar powered oxygen and Oxygen from cylinders in people with Pneumonia and Hypoxemia, run by University of Alberta at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of hospital stay (time frame: Until end of hospitalization (usually 3 to 7 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02100865, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.

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