超低潮气量通气对新冠肺炎ARDS患者1年功能结果的影响。随机对照试验的长期随访分析

摘要(中文译文)

超低潮气量通气(ULTV)旨在减轻急性呼吸窘迫综合征(ARDS)患者的呼吸机相关性肺损伤,但与动脉血二氧化碳分压(PaCO)升高相关。本随访研究旨在评估ULTV是否影响VT4COVID试验中预先设定的长期次要结局。VT4COVID是一项在法国十家重症监护病房开展的非盲、多中心、随机对照优效性试验。纳入患者为2019冠状病毒病相关ARDS患者,其动脉血氧分压(PaO)与吸入氧浓度(FiO)比值≤150 mmHg,随机分配至潮气量(VT)为4 mL/kg预测体重(PBW)的ULTV组,或VT为6 mL/kg PBW的低潮气量通气(LTV)组。受试者、研究者和结局评估者对分组均非盲。以下预先设定的次要结局在第365天进行评估:MoCA 5分钟量表、SF-36和IES-R评分;第365天死亡率作为结局事后追加。各评分采用Mann-Whitney检验进行组间比较,死亡率采用Cox比例风险模型进行组间比较。除第365天死亡率外,所有分析均按改良意向性治疗原则进行。2020年4月至2021年4月期间,共215例患者被随机分配至ULTV组(n=106)或LTV组(n=109)。7例患者失访,34例存活患者至少有一项评分数据缺失。ULTV组与LTV组第365天死亡率无显著差异(47/102[46%]对44/106[42%],风险比1.19,95%置信区间(CI):0.79-1.80)。其他次要结局分别在ULTV组39/55例(71%)和LTV组44/62例(71%)患者中评估。ULTV组MoCA 5分钟量表评分显著较低(中位差值:-2[CI:-4~0]分,p<0.05)。两组间SF-36和IES-R评分无显著差异。在一项事后分析中,MoCA 5分钟量表评分与ARDS管理期间曲线下面积(AUC)或最大PaCO显著相关(p<0.01),而与AUC或最小PaO无关。ULTV与第365天认知状态小幅但显著的下降相关,可能与暴露于较高PaCO有关。该试验于2020年4月16日在ClinicalTrials.gov前瞻性注册(NCT04349618)。

Abstract

Ultra-low tidal volume ventilation (ULTV) aims to minimize ventilator-induced lung injury in acute respiratory distress syndrome (ARDS), but is associated with an increase in arterial carbon dioxide (PaCO). This follow-up study aimed to evaluate whether ULTV impacted long-term pre-specified secondary outcomes in the VT4COVID trial. VT4COVID was an open-label multicenter randomized controlled superiority trial performed in ten French intensive care units. Eligible patients were COVID-19 ARDS patients with arterial oxygen pressure (PaO) over inspired oxygen fraction (FiO) ≤ 150 mmHg, randomized to ULTV with tidal volume (VT) 4 mL.kg predicted body weight (PBW), or low VT ventilation (LTV) with VT 6 mL.kg PBW. Participants, investigators, and outcome assessors were unblinded to group assignment. The following prespecified secondary outcomes were assessed at day-365: MoCA 5-minute, SF-36 and IES-R scores; mortality at day-365 was added a posteriori as an outcome. Scores were compared between arms with the Mann-Whitney test, and mortality was compared between groups with a Cox proportional-hazard model. All analyses (except mortality at day-365) were conducted according to a modified intention-to-treat principle. Two hundred and fifteen patients were randomized to ULTV (n = 106) or LTV (n = 109) between April,2020 and April,2021. Seven patients were lost to follow-up and 34 surviving patients had missing data for at least one score. Mortality at day-365 was not significantly different between ULTV and LTV arms (47/102 [46%] vs. 44/106 [42%], hazard ratio 1.19 (95% confidence interval (CI):0.79-1.80)). The other secondary outcomes were evaluated in 39/55 [71%] and 44/62 [71%] patients in the ULTV and LTV arm, respectively. The MoCA 5-minute score was significantly lower in the ULTV arm (median difference: -2 [CI:-4-0] points, p < 0.05). There was no significant difference in SF-36 and IES-R scores between groups. In a post-hoc analysis, MoCA 5-minute score was significantly associated with area under curve (AUC) or maximal PaCO during ARDS management (p < 0.01), but not with AUC or minimal PaO. ULTV is associated with a small but significant decrease in cognitive status at day-365 possibly related to exposure to higher PaCO. The trial was prospectively registered with ClinicalTrials.gov (NCT04349618) on April 16, 2020.

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