有创–高流量氧疗与有创–无创通气序贯治疗慢性阻塞性肺疾病并严重呼吸衰竭的随机对照研究

Invasive high-flow oxygen therapy and invasive-noninvasive ventilation sequential strategies for chronic obstructive pulmonary disease patients with severe respiratory failure: a randomized controlled trial

目的对比有创–高流量氧疗(HFNC)和有创–无创通气(NIV)序贯治疗对慢性阻塞性肺疾病(简称慢阻肺)并严重呼吸衰竭的治疗效果,探讨慢阻肺合并呼吸衰竭有创通气拔管后HFNC治疗的可行性。方法2017年10月至2019年10月重症加强治疗病房(ICU)收治的诊断为慢阻肺且合并Ⅱ型呼吸衰竭行有创通气的患者,经抗感染等治疗后出现肺部感染控制窗,按1∶1随机分为HFNC组和NIV组。HFNC组拔管后接受HFNC治疗,NIV组拔管后接受NIV治疗。主要观察终点为治疗失败率,次要观察终点为拔管后1 h、24 h及48 h的血气分析参数和生命体征、拔管后呼吸支持总时间、每日气道护理干预次数、舒适度评分、鼻面部皮损发生率、ICU住院时间、总住院时间及拔管后28天病死率等。结果112例患者进入随机分组,经二次排除后HFNC组和NIV组分别有53例和52例纳入分析。HFNC组治疗失败率为22.6%,低于NIV组的28.8%,失败率风险差为–6.2%(95%CI–22.47~10.43,P=0.509),显著低于9%的非劣效界值。治疗失败原因分析显示HFNC组治疗不耐受显著低于NIV组,风险差–38.4%(95%CI–62.5~–3.6,P=0.043)。拔管后1 h两组呼吸频率均较拔管前增快(P<0.05),拔管后24 h,HFNC组呼吸频率下降至基线水平,但NIV组呼吸频率仍高于基线水平,且HFNC组低于NIV组[(19.1±3.8)比(21.7±4.5)次/min,P<0.05],拔管后48 h,两组呼吸频率均较基线水平无显著差异。NIV组平均每日气道护理干预为9(5~12)次,显著高于HFNC组的5(4~7)次(P=0.006)。HFNC组舒适度评分显著高于NIV组[(8.6±3.2)比(5.7±2.8)分,P=0.022],而鼻面部皮损发生率显著低于NIV组(0比9.6%,P=0.027)。两组呼吸困难评分、住院时间及28天病死率差异无统计学意义。结论有创-HFNC序贯治疗慢阻肺合并严重呼吸衰竭非劣效于有创-NIV序贯策略,两组具有类似的治疗失败率,且HFNC具有更佳的舒适性和治疗耐受性。

Objective To compare the therapeutic effects of invasive-high-flow oxygen therapy(HFNC)and invasive-non-invasive ventilation(NIV)sequential strategies on severe respiratory failure caused by chronic obstructive pulmonary disease(COPD),and explore the feasibility of HFNC after extubation from invasive ventilation for COPD patients with severe respiratory failure.Methods From October 2017 to October 2019,COPD patients with typeⅡrespiratory failure who received invasive ventilation were randomly assigned to a HFNC group and a NIV group at 1:1 in intensive care unit(ICU),when pulmonary infection control window appeared after treatments.The patients in the HFNC group received HFNC,while the patients in the NIV group received NIV after extubation.The primary endpoint was treatment failure rate.The secondary endpoints were blood gas analysis and vital signs at 1 hour,24 hours,and 48 hours after extubation,total respiratory support time after extubation,daily airway care interventions,comfort scores,and incidence of nasal and facial skin lesions,ICU length of stay,total length of stay and 28-day mortality after extubation.Results One hundred and twelve patients were randomly assigned to the HFNC group and the NIV group.After secondary exclusion,53 patients and 52 patients in the HFNC group and the NIV group were included in the analysis respectively.The treatment failure rate in the HFNC group was 22.6%,which was lower than the 28.8%in the NIV group.The risk difference of the failure rate between the two groups was–6.2%(95%CI–22.47-10.43,P=0.509),which was significantly lower than the non-inferior effect of 9%.Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group,with a risk difference of–38.4%(95%CI–62.5-–3.6,P=0.043).One hour after extubation,the respiratory rate of both groups increased higher than the baseline level before extubation(P<0.05).24 hours after extubation,the respiratory rate in the HFNC group decreased to the baseline level,but the respiratory rate in the NIV group was still higher than the baseline level,and the respiratory rate in the HFNC group was lower than that in the NIV group[(19.1±3.8)vs.(21.7±4.5)times per minute,P<0.05].48 hours after extubation,the respiratory rates in the two groups were not significantly different from their baseline levels.The average daily airway care intervention in the NIV group was 9(5-12)times,which was significantly higher than the 5(4-7)times in the HFNC group(P=0.006).The comfort score of the HFNC group was significantly higher than that of the NIV group(8.6±3.2 vs.5.7±2.8,P=0.022),while the incidence of nasal and facial skin lesions in the HFNC group was significantly lower than that in the NIV group(0 vs.9.6%,P=0.027).There was no significant difference in dyspnea score,length of stay and 28-day mortality between the two groups.Conclusions The efficacy of invasiveHFNC sequential treatment on COPD with severe respiratory failure is not inferior to that of invasive-NIV sequential strategy.The two groups have similar treatment failure rates,and HFNC has better comfort and treatment tolerance.