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Solar Powered Oxygen Delivery

14. september 2016 opdateret af: University of Alberta

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

130

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Uganda
      • Jinja, Uganda
        • Jinja Regional Referral Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 13 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Solar powered oxygen
Aktiv komparator: Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
Enhed: Oxygen from cylinders

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospital stay
Tidsramme: Until end of hospitalization (usually 3 to 7 days)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mortality
Tidsramme: At hospital discharge (usually 3 to 7 days)
In-hospital mortality will be quantified.
At hospital discharge (usually 3 to 7 days)
Duration of supplemental oxygen therapy
Tidsramme: Until hospital discharge (usually 3 to 7 days)
Time to wean patient off oxygen. This is assessed daily using standard procedures.
Until hospital discharge (usually 3 to 7 days)
Proportion of patients successfully oxygenated
Tidsramme: 6 hours
Success defined as achieving a post-oxygen saturation above 90% within 6 hours.
6 hours
Oxygen delivery system failure
Tidsramme: During hospitalization (usually 3 to 7 days)
Failure defined as need for backup oxygen to maintain SpO2>90%.
During hospitalization (usually 3 to 7 days)
Cost
Tidsramme: Until hospital discharge (usually 3 to 7 days)
Cost of oxygen cylinders (control arm) and cost of equipment (capital investment - solar oxygen intervention arm).
Until hospital discharge (usually 3 to 7 days)
Lambaréné Organ Dysfunction Score (LODS)
Tidsramme: Until hospital discharge (usually 3 to 7 days)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alberta

Efterforskere

  • Ledende efterforsker: Michael T Hawkes, MD, PhD, University of Alberta
  • Ledende efterforsker: Robert O Opoka, MBChB, MPH, Makerere University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2014

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

27. marts 2014

Først indsendt, der opfyldte QC-kriterier

31. marts 2014

Først opslået (Skøn)

1. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0206-01

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner