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提高乌干达西部可靠供氧技术:新生儿和儿科病房分阶段实施试验研究方案。

Technology to improve reliable access to oxygen in Western Uganda: study protocol for a phased implementation trial in neonatal and paediatric wards.

机构信息

FREO2 Foundation, Kampala, Uganda.

Centre for International Child Health, MCRI, Parkville, Victoria, Australia

出版信息

BMJ Open. 2022 Jun 28;12(6):e054642. doi: 10.1136/bmjopen-2021-054642.

Abstract

INTRODUCTION

Oxygen is an essential medicine for children and adults. The current systems for its delivery can be expensive and unreliable in settings where oxygen is most needed. FREO Foundation Australia has developed an integrated oxygen system, driven by a mains-powered oxygen concentrator, with the ability to switch automatically between low-pressure oxygen storage device and cylinder oxygen in power interruptions. The aim of this study is to assess the clinical impact and cost-effectiveness of expanding this system to 20 community and district hospitals and level IV facilities in Western Uganda.

METHODS AND ANALYSIS

This will be a phased implementation with preintervention and postintervention comparison of outcomes. Standardised baseline data collection and needs assessment will be conducted, followed by implementation of the FREO Oxygen System in combination with pulse oximetry in 1-2 facilities per month over a 16-month period, with a total 23-month data collection period. The primary outcome will be the proportion of hypoxaemic children receiving oxygen pre and post oxygen system. Secondary outcomes will assess clinical, economic and technical aspects. Pre and post oxygen system primary and secondary outcomes will be compared using regression models and standard tests of significance. Useability will be quantitatively and qualitatively evaluated in terms of acceptability, feasibility and appropriateness, using standardised implementation outcome measure tools.

ETHICS AND DISSEMINATION

Ethics approval was obtained from Mbarara University of Science and Technology (MUREC 1/7) and the University of Melbourne (2021-14489-13654-2). Outcomes will be presented to the involved facilities, and to representatives of the Ministry of Health, Uganda. Broader dissemination will include publication in peer-reviewed journals and academic conference presentations.

TRIAL REGISTRATION NUMBER

ACTRN12621000241831.

摘要

简介

氧气是儿童和成人的基本药物。在最需要氧气的地方,目前的供氧系统可能既昂贵又不可靠。澳大利亚弗雷奥基金会开发了一种集成的氧气系统,由带有电源的氧气浓缩器驱动,具有在电源中断时自动在低压氧气储存装置和钢瓶氧气之间切换的能力。本研究旨在评估将该系统扩展到乌干达西部 20 家社区和地区医院以及四级设施的临床影响和成本效益。

方法和分析

这将是一个分阶段实施的过程,通过干预前后比较结果。将进行标准化的基线数据收集和需求评估,然后在 16 个月的时间内每月在 1-2 家设施中实施弗雷奥氧气系统,并结合脉搏血氧仪使用,总数据收集期为 23 个月。主要结果将是接受氧气治疗的低氧血症儿童在氧气系统前后的比例。次要结果将评估临床、经济和技术方面。将使用回归模型和标准显著性检验比较氧气系统前后的主要和次要结果。将使用标准化的实施结果衡量工具从可接受性、可行性和适当性方面对可用性进行定量和定性评估。

伦理和传播

已从马凯雷雷大学(MUREC 1/7)和墨尔本大学(2021-14489-13654-2)获得伦理批准。研究结果将提交给参与的机构,并提交给乌干达卫生部的代表。更广泛的传播将包括在同行评议的期刊上发表和学术会议上的演讲。

试验注册号

ACTRN12621000241831。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ab7/9240937/7706a9879cbd/bmjopen-2021-054642f01.jpg

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