Electrical impedance tomography-guided positive end-expiratory pressure and mortality of patients with the acute respiratory distress syndrome: the EITVent randomized clinical trial.

Background

To evaluate whether EIT-guided PEEP improves the clinical outcomes of patients with acute respiratory distress syndrome (ARDS) compared to the lower PEEP/FiO2 table strategy.

评估EIT指导下的PEEP是否能改善急性呼吸窘迫综合征（ARDS）患者的临床结果，与较低的PEEP/FiO2表格策略相比。

Methods

This randomized trial enrolled adult patients with moderate to severe ARDS across five sites in China from February 2022 to June 2023.

这项随机试验招募了2022年2月至2023年6月期间在中国五个地点的中度至重度急性呼吸窘迫综合征(ARDS)成年患者。

Participants were randomly assigned to EIT-guided PEEP (collapse-overdistension crossing point value by decremental PEEP trial) or the classical lower PEEP/FiO2 table.

参与者被随机分配到电机械图(EIT)引导的呼气末正压(PEEP)（通过递减PEEP试验确定的塌陷-过度膨胀交叉点值）或传统的较低PEEP/吸入氧浓度(FiO2)表。

The primary outcome was 28-day mortality.

主要结果是28天内的死亡率。

measurements_and_main_results

The trial was terminated early for futility, based on a pre-planned interim analysis.

基于预先计划的中期分析，试验因无效而提前终止。

A total of 190 patients were included and completed follow-up.

共有190名患者被纳入研究并完成了随访。

PEEP levels didn't differ between groups during the first 7 days (difference in marginal means 0.2 [SE 0.1]; P = .187).

在最初的7天内，两组之间的PEEP水平没有差异（边际均值差异0.2 [标准误0.1]；P = .187）。

At 28 days, mortality was 52 patients (55.9%) in the EIT-guided PEEP group and 51 patients (52.6%) in the lower PEEP/FiO2 table group (hazard ratio[HR] 0.96 [95% CI, 0.65-1.41]; P = .821).

在28天时，EIT指导的PEEP组有52名患者（55.9%）死亡，而低PEEP/FiO2表格组有51名患者（52.6%）死亡（风险比[HR] 0.96 [95% 置信区间, 0.65-1.41]; P = .821）。

Ventilator-free days and other secondary clinical and safety outcomes did not differ, either.

机械通气自由日和其他次要的临床和安全性结果也没有差异。

However, EIT-guided PEEP assigned higher PEEP and decreased mortality in patients with higher lung recruitability, as assessed by the recruitment-inflation ratio method (16 [35.6%] of 45 patients vs 27 [60.0%] of 45 patients; HR 0.49 [95% CI, 0.26-0.91]; P = .024).

然而，通过招募膨胀比方法评估的肺可招募性较高的患者，使用电机械阻抗断层成像（EIT）指导的呼气末正压（PEEP）分配了更高的PEEP，并降低了死亡率（45名患者中有16名[35.6%]对比45名患者中有27名[60.0%]；风险比HR 0.49 [95% 置信区间，0.26-0.91]；P = .024）。

Conclusions

In patients with moderate to severe ARDS, EIT-guided PEEP did not significantly reduce 28-day mortality compared with the lower PEEP/FiO2 table strategy.

在中度至重度急性呼吸窘迫综合征（ARDS）患者中，与较低PEEP/FiO2表格策略相比，使用EIT指导的PEEP并没有显著降低28天的死亡率。

Due to early termination, the study may have been underpowered to detect a clinically important difference.

由于研究提前终止，可能无法检测到具有临床重要性的差异。

trial_registration

clinicaltrials.gov NCT05207202.

clinicaltrials.gov NCT05207202。