Deferring Arterial Catheterization in Critically Ill Patients with Shock.

Methods

In this multicenter, open-label, noninferiority trial, we randomly assigned patients who had shock and had been admitted to an intensive care unit within the past 24 hours to receive early insertion (<4 hours after randomization) of an arterial catheter (invasive strategy) or to be monitored with an automated brachial cuff (noninvasive strategy).

在这项多中心、开放标签、非劣效试验中，我们随机分配了在过去24小时内因休克被收入重症监护病房的患者，接受早期动脉导管置入（<4小时后随机分配）（侵入性策略）或使用自动肱动脉袖带监测（非侵入性策略）。

Insertion of an arterial catheter was allowed later in patients assigned to the noninvasive-strategy group who met prespecified safety criteria.

允许在符合预先设定安全标准的非侵入性策略组患者中较晚插入动脉导管。

The primary outcome was death from any cause at day 28 (noninferiority margin, 5 percentage points).

主要结果是在第28天因任何原因导致的死亡（非劣效性边界，5个百分点）。

Adverse events of special interest related to the blood-pressure-monitoring device that was used were recorded, as was patient-reported pain or discomfort related to the ongoing presence of the device.

记录了与使用血压监测设备相关的特殊关注的不良事件，以及患者报告的与设备持续存在相关的疼痛或不适。

Results

A total of 1010 patients underwent randomization; 504 patients assigned to the noninvasive-strategy group and 502 assigned to the invasive-strategy group were included in the analyses.

共有1010名患者进行了随机分组；504名被分配到非侵入性策略组，502名被分配到侵入性策略组，这些患者被纳入分析。

A total of 74 patients (14.7%) in the noninvasive-strategy group and 493 (98.2%) in the invasive-strategy group underwent insertion of an arterial catheter.

非侵入性策略组共有74名患者（14.7%）和侵入性策略组共有493名患者（98.2%）接受了动脉导管置入。

Death within 28 days occurred in 173 patients (34.3%) in the noninvasive-strategy group and 185 (36.9%) in the invasive-strategy group (adjusted risk difference, -3.2 percentage points; 95% confidence interval, -8.9 to 2.5; P = 0.006 for noninferiority).

非侵入性策略组中有173名患者（34.3%）在28天内死亡，而侵入性策略组中有185名患者（36.9%）死亡（调整后的风险差异为-3.2个百分点；95%置信区间为-8.9至2.5；P=0.006，用于非劣效性检验）。

Results of per-protocol analyses were similar in the two groups.

按方案分析的结果在两组中相似。

A total of 66 patients (13.1%) in the noninvasive-strategy group and 45 (9.0%) in the invasive-strategy group had at least 1 day of pain or discomfort related to the ongoing presence of the blood-pressure-monitoring device.

非侵入性策略组共有66名患者（13.1%）和侵入性策略组有45名患者（9.0%）因持续存在的血压监测设备而至少有一天的疼痛或不适感。

Hematoma or hemorrhage related to the arterial catheter occurred in 5 patients (1.0%) in the noninvasive-strategy group and 41 patients (8.2%) in the invasive-strategy group.

在非侵入性策略组中，有5名患者（1.0%）出现了与动脉导管相关的血肿或出血，在侵入性策略组中，有41名患者（8.2%）出现了此类情况。

Conclusions

Among patients with shock, results for death from any cause at day 28 indicated that management without early arterial catheter insertion was noninferior to early catheter insertion.

对于休克患者，28天内任何原因导致的死亡结果显示，没有早期动脉导管插入的管理方式与早期导管插入相比，并不劣效。

(Funded by the French Ministry of Health; ClinicalTrials.gov number, NCT03680963.).

(由法国卫生部资助; ClinicalTrials.gov编号, NCT03680963.)