近日，法国巴黎城市大学Lila Bouadma团队研究了危重患者的局限性与自由性身体约束策略对患者预后的影响。该研究于2026年3月17日发表在《美国医学会志》上。

腕部物理约束对重症监护病房（ICU）机械通气患者预后的影响仍不确定。

为了探讨限制性腕部物理约束策略在ICU有创机械通气危重症患者中的应用效果，2021年1月5日至2024年1月2日，研究组在法国10个ICU开展了一项开放标签随机临床试验，共纳入405例启动有创机械通气≤6小时且预期通气时间≥48小时的成年患者。随访于2024年5月17日完成。统计分析时间为2025年6月1日至12月15日。

患者随机接受两种约束策略：限制性低使用策略组（n=201）——除非因严重躁动（里士满躁动-镇静量表评分≥3分，量表范围-5分[无反应]至4分[有攻击性]）必须使用外，尽量避免腕部约束；开放性高使用策略组（n=204）——常规系统使用腕部约束并每日评估。清醒或无谵妄（通过ICU意识模糊评估法测量）拔管患者可解除约束。主要终点为随机化后14天内无昏迷或谵妄的存活天数。次要终点包括自行拔管发生率和90天死亡率。

在具有主要结局数据的396例患者中，中位年龄65岁（IQR 56-73），男性245例（62%），中位序贯器官衰竭评分7分（IQR 4-10）。低使用策略组无昏迷或谵妄平均存活天数为6.67天（95%CI 5.69-7.65），高使用策略组为6.30天（95%CI 5.35-7.24）（校正后平均差0.37天[95%CI -0.71至1.46]；P=0.51）。低使用策略组18例（9.2%）发生自行拔管，高使用策略组17例（8.5%）；90天死亡率分别为37.2%和41.0%。

这项随机临床试验表明，在ICU接受机械通气的成年患者中，与高使用腕部约束策略相比，低使用腕部物理约束策略并未减少14天内无谵妄或昏迷的天数。

附：英文原文

Title: Restrictive vs Liberal Physical Restraint Strategies in Critically Ill Patients: The R2D2-ICU Randomized Clinical Trial

Author: Romain Sonneville, Camille Couffignal, Florian Sigaud, Michael Thy, Virginie Godard, Juliette Audibert, Damien Contou, Adam Celier, Michel Djibré, Thomas Rambaud, Pierre Jaquet, Armand Mekontso Dessap, Claire Bourel, Romane Belot, Carine Roy, Fariza Nait Sidenas, Fatiha Essardy, Jean-Franois Timsit, Renaud Cornic, Lila Bouadma, RD-ICU Investigator Study Group, Gwenole ABGRALL, Romain ARRESTIER, Juliette AUDIBERT, Jean-Loup AUGY, Franois BAGATE, Pierre BAY, Erwan BEGOT, Adel BEN SALAH, Brice BENELLI, Enora BERTI, Astrid BERTIER, Alexandra BEURTON, Pierre-Antoine BILLIET, Lila BOUADMA, Joanna BOUGNAUD, Anne-Laure BOUILLAND, Mohamed BOUJELBEN, Cme BUREAU, Clara CANDILLE, Erwann CARIOU, Guillaume CARTEAUX, Jenifer CATANO, Pedro CAVALEIRO, Adam CELIER, Pierre CHAFIOTTE, Giulia CIRILLO, Sébastien CLERC, Alexandre CONIA, Charlotte CORDIER, Louis-Marie COUPRY, Daniel DA SILVA, Anais DARTEVEL, Etienne DE MONTMOLLIN, Nina DE MONTMOLLIN, Nicolas DE PROST, Maxens DECAVELE, Robin DELERIS, Cyrielle DESNOS, Julien DESSAJAN, Marie-Claire DIEMOZ, Hermann DO REGO, Julien DO VALE, Martin DRES, Etienne DUFRANC, Michael EJZENBERG, Alexandre ELABBADI, Pierre-Edouard FLOCH, Quentin FOSSE, Thomas FRAPARD, Antoine GAILLET, Louis-Marie GALERNEAU, Ségolène GENDREAU

Issue&Volume: 2026-03-17

Abstract:

Importance  The effect of wrist-strap physical restraints on outcomes in patients receiving mechanical ventilation in the intensive care unit (ICU) remains uncertain.

Objective  To investigate the effect of a low-use wrist-strap physical restraint strategy in critically ill patients receiving invasive mechanical ventilation.

Design, Setting, and Participants  Open-label randomized clinical trial conducted across 10 ICUs in France. Between January 5, 2021, and January 2, 2024, 405 adult patients who had initiated invasive mechanical ventilation within the previous 6 hours and were expected to require ventilation for at least 48 hours were enrolled. Follow-up was completed on May 17, 2024. Statistical analysis was conducted from June 1, 2025, to December 15, 2025.

Interventions  Patients were randomized to undergo either a restrictive, low-use physical restraint strategy (wrist straps avoided unless necessary because of severe agitation, defined as a Richmond Agitation-Sedation Scale score of ≥3 [on a scale from 5 (unresponsive) to 4 (combative)]; n=201) or a liberal, high-use strategy (wrist straps applied systematically and reassessed daily; n=204). Discontinuation of restraints was allowed in patients who were awake or extubated without delirium (measured via the Confusion Assessment Method for the ICU).

Main Outcomes and Measures  The primary outcome was the number of days alive without coma or delirium during the first 14 days after randomization. Secondary outcomes included incidence of self-extubation and day-90 mortality.

Results  Among 396 patients with available primary outcome data, the median (IQR) age was 65 (56-73) years, 245 (62%) were male, and the median (IQR) Sequential Organ Failure Assessment score was 7 (4-10). The mean days alive without coma or delirium were 6.67 days (95% CI, 5.69-7.65) in the low-use strategy group and 6.30 days (95% CI, 5.35-7.24) in the high-use strategy group (adjusted mean difference, 0.37 days [95% CI, 0.71 to 1.46]; P=.51). Self-extubation occurred in 18 patients (9.2%) in the low-use strategy group and 17 (8.5%) in the high-use strategy group, and day-90 mortality was 37.2% and 41.0%, respectively.

Conclusions and Relevance  In this randomized clinical trial, among adult patients receiving mechanical ventilation in the ICU, a low-use wrist-strap physical restraint strategy compared with a high-use strategy did not reduce days free of delirium or coma at 14 days.

DOI: 10.1001/jama.2026.2897

Source: https://jamanetwork.com/journals/jama/fullarticle/2846726