PDF(Pubmed)
Abstract：
BACKGROUND: Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.
METHODS: This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.
BACKGROUND: The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.
BACKGROUND: NCT04693403.
METHODS: 8 September 2023; version 5.
METHODS: This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.
BACKGROUND: The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.
BACKGROUND: NCT04693403.
METHODS: 8 September 2023; version 5.
摘要：
背景：在撒哈拉以南非洲地区，急性低氧血症性呼吸衰竭（AHRF）与高死亡率相关。这至少部分是由于重症监护相关的资源限制，包括有限的侵入性机械通气和/或高技能的急性护理人员。持续气道正压通气（CPAP）和经鼻插管的高流量氧气（HFNC）可能有助于减少插管，因此,改善危重患者的生存结果，特别是在资源有限的环境中，但在这样的设置数据缺乏。这项研究的目的是确定CPAP或HFNC与标准氧疗相比，在资源有限的情况下，可以降低患有AHRF的成年人的死亡率。
方法：这是一个前瞻性的，多中心,随机化，控制,阶梯式楔形试验，在乌干达接受AHRF治疗的患者将被随机分配到通过面罩提供的标准氧疗中，HFNC氧气或CPAP。主要结果是28天时的全因死亡率。次要结果包括第7天符合插管标准的患者人数，第28天插管的患者人数，第28天的无呼吸机天数以及每种呼吸支持的耐受性。
背景：该研究已获得研究与伦理委员会的伦理批准，生物医学科学学院,健康科学学院,马凯雷雷大学以及乌干达国家科学技术委员会。患者将在知情同意后纳入。结果将提交在同行评审的期刊上发表。
背景：NCT04693403。
方法：2023年9月8日；版本5。
方法：这是一个前瞻性的，多中心,随机化，控制,阶梯式楔形试验，在乌干达接受AHRF治疗的患者将被随机分配到通过面罩提供的标准氧疗中，HFNC氧气或CPAP。主要结果是28天时的全因死亡率。次要结果包括第7天符合插管标准的患者人数，第28天插管的患者人数，第28天的无呼吸机天数以及每种呼吸支持的耐受性。
背景：该研究已获得研究与伦理委员会的伦理批准，生物医学科学学院,健康科学学院,马凯雷雷大学以及乌干达国家科学技术委员会。患者将在知情同意后纳入。结果将提交在同行评审的期刊上发表。
背景：NCT04693403。
方法：2023年9月8日；版本5。
