背景:尽管累积研究表明,高流量鼻插管吸氧(HFNC)在急性高碳酸血症性呼吸衰竭中具有有益作用,在慢性阻塞性肺疾病急性加重(AECOPD)合并急性-中度高碳酸血症性呼吸衰竭患者中,比较HFNC和无创通气(NIV)作为初始治疗的随机试验是有限的.这个随机化的目的,开放标签,非劣效性试验旨在比较HFNC和NIV患者的治疗失败率.
方法:在2018年3月至2022年12月期间,被诊断为AECOPD且基线动脉血气pH值在7.25至7.35之间且PaCO2≥50mmHg的患者在一家大型三级教学医院的两个重症监护病房(ICU)被随机分配到HFNC或NIV。主要终点是治疗失败率,定义为气管内插管或切换到其他研究治疗方式。次要终点是插管率或治疗改变率,血气值,在一个生命体征,12和48小时,28天死亡率,以及ICU和医院的住院时间。
结果:共有225例患者(HFNC组113例,NIV组112例)被纳入意向治疗分析。HFNC组的失败率为25.7%,而NIV组为14.3%。两组的失败率风险差异为11.38%(95%CI0.25-21.20,P=0.033),高于9%的非劣效性截止值。在符合方案的分析中,治疗失败发生在HFNC组110例患者中的28例(25.5%)和NIV组109例患者中的15例(13.8%)(风险差异,11.69%;95%CI0.48-22.60)。HFNC组的插管率高于NIV组(14.2%vs5.4%,P=0.026)。治疗切换率,HFNC组与NIV组相比,ICU、住院时间及28天死亡率差异均无统计学意义(均P>0.05)。
结论:HFNC作为AECOPD伴急性-中度高碳酸血症呼吸衰竭患者的初始呼吸支持时,治疗失败的发生率高于NIV。
背景:chictr.org(ChiCTR1800014553)。2018年1月21日注册,http://www.chictr.org.cn.
BACKGROUND: Although cumulative studies have demonstrated a beneficial effect of high-flow nasal cannula oxygen (HFNC) in acute hypercapnic respiratory failure, randomized trials to compare HFNC with non-invasive ventilation (NIV) as initial treatment in acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients with acute-moderate hypercapnic respiratory failure are limited. The aim of this randomized, open label, non-inferiority
trial was to compare treatment failure rates between HFNC and NIV in such patients.
METHODS: Patients diagnosed with AECOPD with a baseline arterial blood gas pH between 7.25 and 7.35 and PaCO2 ≥ 50 mmHg admitted to two intensive care units (ICUs) at a large tertiary academic teaching hospital between March 2018 and December 2022 were randomly assigned to HFNC or NIV. The primary endpoint was the rate of treatment failure, defined as endotracheal intubation or a switch to the other
study treatment modality. Secondary endpoints were rates of intubation or treatment change, blood gas values, vital signs at one, 12, and 48 h, 28-day mortality, as well as ICU and hospital lengths of stay.
RESULTS: 225 total patients (113 in the HFNC group and 112 in the NIV group) were included in the intention-to-treat analysis. The failure rate of the HFNC group was 25.7%, while the NIV group was 14.3%. The failure rate risk difference between the two groups was 11.38% (95% CI 0.25-21.20, P = 0.033), which was higher than the non-inferiority cut-off of 9%. In the per-protocol analysis, treatment failure occurred in 28 of 110 patients (25.5%) in the HFNC group and 15 of 109 patients (13.8%) in the NIV group (risk difference, 11.69%; 95% CI 0.48-22.60). The intubation rate in the HFNC group was higher than in the NIV group (14.2% vs 5.4%, P = 0.026). The treatment switch rate, ICU and hospital length of stay or 28-day mortality in the HFNC group were not statistically different from the NIV group (all P > 0.05).
CONCLUSIONS: HFNC was not shown to be non-inferior to NIV and resulted in a higher incidence of treatment failure than NIV when used as the initial respiratory support for AECOPD patients with acute-moderate hypercapnic respiratory failure.
BACKGROUND: chictr.org (ChiCTR1800014553). Registered 21 January 2018, http://www.chictr.org.cn.