Esteban Andrés, Frutos-Vivar Fernando, Ferguson Niall D, Arabi Yaseen, Apezteguía Carlos, González Marco, Epstein Scott K, Hill Nicholas S, Nava Stefano, Soares Marco-Antonio, D'Empaire Gabriel, Alía Inmaculada, Anzueto Antonio
Unidad de Cuidados Intensivos, Hospital Universitario de Getafe, Madrid, Spain.
N Engl J Med. 2004 Jun 10;350(24):2452-60. doi: 10.1056/NEJMoa032736.
The need for reintubation after extubation and discontinuation of mechanical ventilation is not uncommon and is associated with increased mortality. Noninvasive positive-pressure ventilation has been suggested as a promising therapy for patients with respiratory failure after extubation, but a single-center, randomized trial recently found no benefit. We conducted a multicenter, randomized trial to evaluate the effect of noninvasive positive-pressure ventilation on mortality in this clinical setting.
Patients in 37 centers in eight countries who were electively extubated after at least 48 hours of mechanical ventilation and who had respiratory failure within the subsequent 48 hours were randomly assigned to either noninvasive positive-pressure ventilation by face mask or standard medical therapy.
A total of 221 patients with similar baseline characteristics had been randomly assigned to either noninvasive ventilation (114 patients) or standard medical therapy (107 patients) when the trial was stopped early, after an interim analysis. There was no difference between the noninvasive-ventilation group and the standard-therapy group in the need for reintubation (rate of reintubation, 48 percent in both groups; relative risk in the noninvasive-ventilation group, 0.99; 95 percent confidence interval, 0.76 to 1.30). The rate of death in the intensive care unit was higher in the noninvasive-ventilation group than in the standard-therapy group (25 percent vs. 14 percent; relative risk, 1.78; 95 percent confidence interval, 1.03 to 3.20; P=0.048), and the median time from respiratory failure to reintubation was longer in the noninvasive-ventilation group (12 hours vs. 2 hours 30 minutes, P=0.02).
Noninvasive positive-pressure ventilation does not prevent the need for reintubation or reduce mortality in unselected patients who have respiratory failure after extubation.
拔管及机械通气停止后再次插管的需求并不罕见,且与死亡率增加相关。无创正压通气已被提议作为拔管后呼吸衰竭患者的一种有前景的治疗方法,但最近一项单中心随机试验未发现其益处。我们进行了一项多中心随机试验,以评估无创正压通气在此临床环境中对死亡率的影响。
来自八个国家37个中心的患者,在接受至少48小时机械通气后选择性拔管,并在随后48小时内出现呼吸衰竭,被随机分配接受面罩无创正压通气或标准药物治疗。
在中期分析后试验提前终止时,共有221例基线特征相似的患者被随机分配至无创通气组(114例患者)或标准治疗组(107例患者)。无创通气组和标准治疗组在再次插管需求方面无差异(两组再次插管率均为48%;无创通气组相对风险为0.99;95%置信区间为0.76至1.30)。无创通气组重症监护病房的死亡率高于标准治疗组(25%对14%;相对风险为1.78;95%置信区间为1.03至3.20;P = 0.048),且无创通气组从呼吸衰竭到再次插管的中位时间更长(12小时对2小时30分钟,P = 0.02)。
无创正压通气不能预防未选择的拔管后呼吸衰竭患者再次插管的需求,也不能降低其死亡率。