- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02100865
Solar Powered Oxygen Delivery
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Jinja, Uganda
- Jinja Regional Referral Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
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Aktiv komparator: Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Length of hospital stay
Tidsram: Until end of hospitalization (usually 3 to 7 days)
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The number of days from admission to discharge.
Criteria for discharge are standardized and are assessed daily.
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Until end of hospitalization (usually 3 to 7 days)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Mortality
Tidsram: At hospital discharge (usually 3 to 7 days)
|
In-hospital mortality will be quantified.
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At hospital discharge (usually 3 to 7 days)
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Duration of supplemental oxygen therapy
Tidsram: Until hospital discharge (usually 3 to 7 days)
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Time to wean patient off oxygen.
This is assessed daily using standard procedures.
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Until hospital discharge (usually 3 to 7 days)
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Proportion of patients successfully oxygenated
Tidsram: 6 hours
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Success defined as achieving a post-oxygen saturation above 90% within 6 hours.
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6 hours
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Oxygen delivery system failure
Tidsram: During hospitalization (usually 3 to 7 days)
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Failure defined as need for backup oxygen to maintain SpO2>90%.
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During hospitalization (usually 3 to 7 days)
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Cost
Tidsram: Until hospital discharge (usually 3 to 7 days)
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Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).
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Until hospital discharge (usually 3 to 7 days)
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Lambaréné Organ Dysfunction Score (LODS)
Tidsram: Until hospital discharge (usually 3 to 7 days)
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This simple published clinical score predicts mortality in children with malaria, but may also have prognostic value in pneumonia.
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Until hospital discharge (usually 3 to 7 days)
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Michael T Hawkes, MD, PhD, University of Alberta
- Huvudutredare: Robert O Opoka, MBChB, MPH, Makerere University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0206-01
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