近日，法国奥尔良大学医院Grégoire Muller团队研究了休克危重病人延期接受动脉导管置入术对预后的影响。该研究于2025年10月29日发表在《新英格兰医学杂志》上。

对于休克患者，无创血压监测是否能有效替代推荐使用的动脉导管尚不确定。

在这项多中心、开放标签、非劣效性的试验中，研究组随机分配了过去24小时内住进重症监护病房的休克患者，让他们接受动脉导管的早期插入（随机化后4小时）（有创策略）或自动肱袖带监测（无创策略）。随后，在符合预先规定的安全标准的无创策略组的患者中，允许插入动脉导管。主要结局是第28天全因死亡（非劣效性裕度，5个百分点）。记录与所使用的血压监测装置相关的特殊不良事件，以及患者报告的与设备持续存在相关的疼痛或不适。

随机分组共1010例患者；504名患者被分配到无创策略组，502名患者被分配到有创策略组纳入分析。无创组74例（14.7%）患者和有创组493例（98.2%）患者接受了动脉导管插入。无创策略组有173例（34.3%）患者在28天内死亡，有创策略组有185例（36.9%）患者在28天内死亡（调整后的风险差异为3.2个百分点；95%可信区间为8.9 ~ 2.5；非效性P=0.006）。两组的方案分析结果相似。无创策略组共有66例（13.1%）患者和有创策略组45例（9.0%）患者因持续使用血压监测装置而出现至少1天的疼痛或不适。无创组5例（1.0%）发生血肿或出血，有创组41例（8.2%）发生血肿或出血。< br / >结果:对于第28天任何原因的死亡，表明不早期动脉导管插入的处理与早期导管插入的处理不差。

研究结果表明，不进行早期动脉导管插入治疗的休克患者，第28天全因死亡结局并不劣于早期导管插入。

附：英文原文

Title: Deferring Arterial Catheterization in Critically Ill Patients with Shock

Author: Grégoire Muller, Damien Contou, Stephan Ehrmann, Malle Martin, Pascal Andreu, Toufik Kamel, Florence Boissier, Marie-Ange Azais, Alexandra Monnier, Sylvie Vimeux, Amélie Chenal, Mai-Anh Nay, Charlotte Salmon Gandonnière, Jean-Baptiste Lascarrou, Jean-Baptiste Roudaut, Gatan Plantefève, Bruno Giraudeau, Karim Lakhal, Elsa Tavernier, Thierry Boulain

Issue&Volume: 2025-10-29

Abstract:

BACKGROUND

In patients with shock, whether noninvasive blood-pressure monitoring is an effective alternative to the recommended use of an arterial catheter is uncertain.

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). Insertion of an arterial catheter was allowed later in patients assigned to the noninvasive-strategy group who met prespecified safety criteria. The primary outcome was death from any cause at day 28 (noninferiority margin, 5 percentage points). 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.

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

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.

DOI: 10.1056/NEJMoa2502136

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2502136