- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02100865
Solar Powered Oxygen Delivery
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Jinja, Uganda
- Jinja Regional Referral Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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Comparador activo: Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of hospital stay
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mortality
Periodo de tiempo: At hospital discharge (usually 3 to 7 days)
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael T Hawkes, MD, PhD, University of Alberta
- Investigador principal: Robert O Opoka, MBChB, MPH, Makerere University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0206-01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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