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早期气管造口术不能改善接受机械通气重度中风患者6个月时的功能预后
作者:小柯机器人 发布时间:2022/5/8 22:26:07

德国卡塞尔医院Julian Bösel团队研究了早期与标准气管造口术对接受机械通气的重度中风患者6个月时功能预后的影响。该研究于2022年5月4日发表在《美国医学会杂志》上。

许多重度中风患者的气道保护反射受损,导致有创机械通气时间延长。

为了检测早期气管造口术与标准气管造口术相比是否能改善接受机械通气中风患者的功能预后,研究组进行了一项随机临床试验,2015年7月28日至2020年1月24日,在26家美国和德国神经重症监护中心招募了382名接受有创通气的严重急性缺血性或出血性中风患者,将其按1:1随机分配,分别进行早期气管造口术(插管5天内)或从第10天开始,若有需要,使用标准气管造口术进行呼吸机脱机。最终随访日期为2020年8月9日。

随机分组后,早期气管造口术组(早期组)188例,标准气管造口术组(对照组)194例。主要结局是6个月时的功能预后,基于改良的Rankin量表评分(范围为0[最佳]至6[最差]),分为0分(无残疾)至4分(中重度残疾)与5分(重度残疾)或6分(死亡)。

382名随机分组的患者中位年龄为59岁;49.8%为女性,366名(95.8%)完成了试验,并获得了主要结局的随访数据,其中早期组177名患者(94.1%),标准组189名患者(97.4%)。95.2%的早期组患者在插管后中位4天进行气管造口术(主要经皮),67%的对照组患者在插管后中位11天进行。

6个月时,早期组与对照组相比,无严重残疾的患者比例(改良Rankin评分,0-4)无显著差异,分别为43.5%与47.1%,校正后的优势比为0.93。在严重不良事件中,早期气管造口术组中有5.0%(121例报告事件中有6例)与气管造口相关,对照组中有3.4%(118例报告事件中有4例)相关。

研究结果表明,在接受机械通气治疗的重度中风患者中,与标准气管造口术相比,早期气管造口术并没有显著提高6个月时无严重残疾的存活率。然而,疗效评估的广泛置信区间可能包括临床上重要差异,因此不能排除早期气管造口策略的临床相关益处或危害。

附:英文原文

Title: Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial

Author: Julian Bsel, Wolf-Dirk Niesen, Farid Salih, Nicholas A. Morris, Jeremy T. Ragland, Bryan Gough, Hauke Schneider, Jan-Oliver Neumann, David Y. Hwang, Phani Kantamneni, Michael L. James, William D. Freeman, Venkatakrishna Rajajee, Chethan Venkatasubba Rao, Deepak Nair, Laura Benner, Jan Meis, Christina Klose, Meinhard Kieser, José I. Suarez, Silvia Schnenberger, David B. Seder, SETPOINT and the IGNITE Study Groups, Ahmad Ramadan, Jan Claassen, Stephan Mayer, Harry Peled, Thomas Christianson, Teresa L. May, Richard R. Riker, Golschan Asgarpur, Henning Stetefeld, Stefan Kluge

Issue&Volume: 2022-05-04

Abstract:

Importance  Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation.

Objective  To test whether early vs standard tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation.

Design, Setting, and Participants  In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020.

Interventions  Patients were assigned to an early tracheostomy strategy (n=188) or to a standard tracheostomy (control group) strategy (n=194).

Main Outcomes and Measures  The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 [best] to 6 [worst]) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death).

Results  Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients [94.1%] in the early group; 189 patients [97.4%] in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, 3.6% [95% CI, 14.3% to 7.2%]; adjusted odds ratio, 0.93 [95% CI, 0.60-1.42]; P=.73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy.

Conclusions and Relevance  Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded.

DOI: 10.1001/jama.2022.4798

Source: https://jamanetwork.com/journals/jama/fullarticle/2792016

期刊信息

JAMA-Journal of The American Medical Association:《美国医学会杂志》,创刊于1883年。隶属于美国医学协会,最新IF:51.273
官方网址:https://jamanetwork.com/
投稿链接:http://manuscripts.jama.com/cgi-bin/main.plex