- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02100865
Solar Powered Oxygen Delivery
Solar Powered Oxygen Delivery: An Open-label Non-inferiority Comparison to Standard Oxygen Delivery Using Oxygen Cylinders
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Jinja, 우간다
- Jinja Regional Referral Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: Oxygen from cylinders
Conventional oxygen delivery from compressed gas cylinders
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Length of hospital stay
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mortality
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael T Hawkes, MD, PhD, University of Alberta
- 수석 연구원: Robert O Opoka, MBChB, MPH, Makerere University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0206-01
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Solar powered oxygen에 대한 임상 시험
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University of ArizonaNational Cancer Institute (NCI)완전한
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Institut de Myologie, France모병근이영양증 | 미토콘드리아 근병증 | 글리코겐 축적병 | 특발성 염증성 근병증 | 선천성 근병증프랑스
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Healthcare Innovation Technology LabNovo Nordisk A/S알려지지 않은
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University Hospital, Basel, Switzerland모병