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[JAMA在线发表]:拔管后使用无创通气及高流量鼻导管氧疗对比单纯高流量鼻导管氧疗对拔管失败高危患者再次插管的影响
2019年10月09日 时讯速递, 进展交流 暂无评论

Original Investigation Caring for the Critically Ill PatientOctober 2, 2019

Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial

Arnaud W. Thille, Grégoire Muller, Arnaud Gacouin, et al

JAMA. Published online October 2, 2019. doi:10.1001/jama.2019.14901

Importance 背景

High-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation.

高流量鼻导管氧疗可以预防ICU中拔管后呼吸功能衰竭。联合应用高流量鼻导管氧疗与无创通气(NIV)可能是避免再次插管的适宜通气策略。

Objective 目的

To determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU.

确定对于拔管失败高危ICU患者,与单纯高流量鼻导管氧疗相比,拔管后立即使用高流量鼻导管氧疗联合预防性NIV能否降低再插管率。

Design, Setting, and Participants 试验设计,场景及研究对象

Multicenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018.

这项多中心随机临床试验于2017年4月至2018年1月在法国30个ICU进行,纳入641名拔管高危(即年龄65岁以上,或具有心脏或呼吸系统基础疾病)患者;最后随访至2018年4月。

Interventions 干预措施

Patients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen with NIV (n = 342) immediately after extubation.

患者被随机分组,在拔管后立即接受单纯高流量鼻导管氧疗(n = 306) 或高流量鼻导管氧疗联合NIV (n = 342)。

Main Outcomes and Measures 主要预后指标

The primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality.

主要预后指标为第7天时再次插管患者比例;次要预后指标包括第7天时拔管后呼吸功能衰竭,至转出ICU时再次插管比例,以及ICU病死率。

Results 结果

Among 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, −6.4% [95% CI, −12.0% to −0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, −8.7% [95% CI, −15.2% to −1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference −7.4% [95% CI, −13.2% to −1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, −2.4% [95% CI, −6.7% to 1.7%]; P = .25).

总共 648 名患者接受随机分组 (平均 [SD] 年龄, 70 [10] 岁; 219 名女性 [34%]),其中 641 名患者完成试验。高流量鼻导管氧疗联合NIV组第7天时再次插管比例为 11.8% (95% CI, 8.4%-15.2%) (40/339),单纯高流量鼻导管氧疗组为 18.2% (95% CI, 13.9%-22.6%) (55/302) (差异, −6.4% [95% CI, −12.0% to −0.9%]; P = .02)。在11个预先确定的次要预后指标中,6项指标无显著差异。与单纯高流量鼻导管氧疗相比,高流量鼻导管氧疗联合NIV组第7天时拔管后呼吸功能衰竭比例 (21% vs 29%; 差异, −8.7% [95% CI, −15.2% to −1.8%]; P = .01) 及转出ICU时再次插管率 (12% vs 20%, 差异 −7.4% [95% CI, −13.2% to −1.8%]; P = .009) 显著降低。ICU病死率无显著差异:高流量鼻导管氧疗联合NIV组为6%,单纯高流量鼻导管氧疗组为9% (差异, −2.4% [95% CI, −6.7% to 1.7%]; P = .25)。

Conclusions and Relevance 结论与意义

In mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.

对于具有拔管失败高危因素的机械通气患者,与单纯高流量鼻导管氧疗相比,拔管后立即使用高流量鼻导管氧疗联合NIV能够显著降低再次插管风险。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT03121482

评论[仅代表个人观点]

  • HFNC的研究仍然是热门话题之一,尽管本研究的出发点和研究人群与既往HFNC的研究有所不同
  • 事实上,有关HFNC的诸多RCT无不说明,选择适当的人群,给予正确的呼吸支持治疗措施,才有可能改善临床结局
  • 顺便想一想,我们是否真的熟悉我们每天都在使用的各种氧疗设备?

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