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慢性呼吸疾病患者拔管后间歇性无创通气:一项多中心随机对照试验(VHYPRE)。

Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER).

机构信息

Service de Réanimation Médicale, Hôpital Pellegrin-Tripode, Centre Hospitalier Universitaire (CHU) de Bordeaux, 1 Place Amélie Raba-Léon, 33076, Bordeaux, France.

Centre de Recherche Cardio-Thoracique, INSERM 1045, CIC 0005, Université de Bordeaux, Bordeaux, France.

出版信息

Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.

DOI:10.1007/s00134-017-4785-1
PMID:28393258
Abstract

PURPOSE

Early noninvasive ventilation (NIV) after extubation decreases the risk of respiratory failure and lowers 90-day mortality in patients with hypercapnia. Patients with chronic respiratory disease are at risk of extubation failure. Therefore, it could be useful to determine the role of NIV with a discontinuous approach, not limited to patients with hypercapnia. We assessed the efficacy of early NIV in decreasing respiratory failure after extubation in patients with chronic respiratory disorders.

METHODS

A prospective randomized controlled multicenter study was conducted. We enrolled 144 mechanically ventilated patients with chronic respiratory disorders who tolerated a spontaneous breathing trial. Patients were randomly allocated after extubation to receive either NIV (NIV group, n = 72), performed with a discontinuous approach, for the first 48 h, or conventional oxygen treatment (usual care group, n = 72). The primary endpoint was decreased respiratory failure within 48 h after extubation. Analysis was by intention to treat. This trial was registered with ClinicalTrials.gov (NCT01047852).

RESULTS

Respiratory failure after extubation was less frequent in the NIV group: 6 (8.5%) versus 20 (27.8%); p = 0.0016. Six patients (8.5%) in the NIV group versus 13 (18.1%) in the usual care group were reintubated; p = 0.09. Intensive care unit (ICU) mortality and 90-day mortality did not differ significantly between the two groups (p = 0.28 and p = 0.33, respectively). Median postrandomization ICU length of stay was lower in the usual care group: 3 days (IQR 2-6) versus 4 days (IQR 2-7; p = 0.008). Patients with hypercapnia during a spontaneous breathing trial were at risk of developing postextubation respiratory failure [adjusted odds ratio (95% CI) = 4.56 (1.59-14.00); p = 0.006] and being intubated [adjusted odds ratio (95% CI) = 3.60 (1.07-13.31); p = 0.04].

CONCLUSIONS

Early NIV performed following a sequential protocol for the first 48 h after extubation decreased the risk of respiratory failure in patients with chronic respiratory disorders. Reintubation and mortality did not differ between NIV and conventional oxygen therapy.

摘要

目的

拔管后早期无创通气(NIV)可降低高碳酸血症患者呼吸衰竭的风险并降低 90 天死亡率。患有慢性呼吸系统疾病的患者有拔管失败的风险。因此,确定 NIV 的作用(不限于高碳酸血症患者)的间断方法可能是有用的。我们评估了早期 NIV 降低慢性呼吸系统疾病患者拔管后呼吸衰竭的疗效。

方法

进行了一项前瞻性随机对照多中心研究。我们纳入了 144 例经机械通气且能耐受自主呼吸试验的慢性呼吸系统疾病患者。拔管后,患者被随机分配接受 NIV(NIV 组,n=72)或常规氧疗(常规治疗组,n=72)。NIV 组在拔管后最初的 48 小时内以间断方式进行,第 49-96 小时给予常规氧疗。主要终点为拔管后 48 小时内呼吸衰竭的发生率。分析为意向治疗。该试验在 ClinicalTrials.gov 上注册(NCT01047852)。

结果

NIV 组拔管后呼吸衰竭的发生率较低:6(8.5%)例与 20(27.8%)例;p=0.0016。NIV 组有 6 例(8.5%)患者需重新插管,而常规治疗组有 13 例(18.1%)患者需重新插管;p=0.09。两组 ICU 死亡率和 90 天死亡率无显著差异(p=0.28 和 p=0.33)。常规治疗组 ICU 住院时间中位数较短:3 天(IQR 2-6)与 4 天(IQR 2-7);p=0.008。自主呼吸试验期间有高碳酸血症的患者有发生拔管后呼吸衰竭的风险[校正比值比(95%CI)=4.56(1.59-14.00);p=0.006]和插管的风险[校正比值比(95%CI)=3.60(1.07-13.31);p=0.04]。

结论

拔管后最初 48 小时内进行序贯 NIV 可降低慢性呼吸系统疾病患者呼吸衰竭的风险。NIV 与常规氧疗的再插管率和死亡率无差异。

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