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.
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。