Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3): A Randomized Clinical Trial.

Transvenous diaphragm neurostimulation can increase diaphragm strength, but its impact on patient outcomes is uncertain.

经静脉膈肌神经刺激可以增加膈肌力量，但其对患者结果的影响尚不确定。

Background

To test the safety and effectiveness of transvenous diaphragm neurostimulation to increase successful weaning in patients with difficulty weaning from mechanical ventilation in comparison with standard of care.

本研究旨在测试经静脉膈神经刺激增加机械通气患者成功脱机的安全性和有效性，与常规护理进行比较。

Methods

This international, multicenter, open-label, randomized clinical trial (RESCUE-3) included adult patients requiring mechanical ventilation for ⩾96 hours who met readiness-to-wean criteria and failed two or more weaning attempts.

这项国际、多中心、开放标签、随机临床试验（RESCUE-3）纳入了需要机械通气96小时及以上的成年患者，这些患者符合脱机标准，但已失败两次或更多次脱机尝试。

Patients were randomized to twice-daily transvenous diaphragm neurostimulation (treatment) or standard of care (control).

患者被随机分配接受每日两次的经静脉膈神经刺激（治疗组）或标准护理（对照组）。

The primary outcome was successful weaning at Day 30.

主要结果是在第30天成功撤机。

Secondary outcomes included duration of ventilation to Day 30 and mortality at Day 30.

次要结果包括第30天的通气持续时间和第30天的死亡率。

The prespecified primary analysis utilized a Bayesian approach with borrowing of prior information from a previous Phase-II randomized trial, downweighted to account for possible differences in trials.

预先设定的主要分析采用贝叶斯方法，利用先前第二阶段随机试验的先验信息进行借力，考虑到试验间可能存在的差异，进行了相应的下调权重处理。

measurements_and_main_results

Because of slow enrollment and financial considerations, the trial was halted at the first interim analysis after 200 patients were randomized.

由于入组缓慢和财务考虑，该试验在首次中期分析时停止，当时已有200名患者随机入组。

Overall, 216 patients were randomized in the modified intent-to-treat population (treatment group, n = 102; control group n = 114).

总体而言，在修改后的意向治疗人群中，共有216名患者被随机入组（治疗组，n = 102；对照组 n = 114）。

At Day 30, 71 (70%) patients in the treatment group and 69 (61%) patients in the control group were successfully weaned (adjusted hazard ratio, 1.34; 95% credible interval = 1.01-1.78; posterior probability of superiority, 97.9%).

在第30天，治疗组中有71名（70%）患者和对照组中有69名（61%）患者成功脱机（调整后风险比，1.34；95%可信区间=1.01-1.78；优越性后验概率，97.9%）。

Treatment reduced the duration of ventilation (adjusted difference, -2.5 d; 95% credible interval = -5.0 to 0.1; posterior probability of superiority, 97.1%).

治疗缩短了通气时间（调整后差异，-2.5天；95%可信区间=-5.0至0.1；优越性后验概率，97.1%）。

Serious adverse events were reported in 36% of patients in the treatment group and 24% of patients in the control group; 9.8% of patients in the treatment group and 10.5% of patients in the control group died (adjusted hazard ratio, 0.74; 95% credible interval = 0.37-1.46; posterior probability of superiority, 80.6%).

治疗组中有36%的患者报告了严重不良事件，而对照组为24%；治疗组有9.8%的患者死亡，对照组为10.5%（调整后的风险比为0.74；95%可信区间=0.37-1.46；优势后验概率为80.6%）。

Conclusions

Although the trial was stopped early because of slow enrollment, transvenous diaphragm neurostimulation showed a high probability of potential benefit for weaning success but with a possible increase in serious adverse events.

尽管由于入组缓慢而提前终止了试验，经静脉膈神经刺激显示出高概率对成功撤机有潜在益处，但可能会增加严重不良事件的发生。