[JAMA在线发表]:常规雾化乙酰半胱氨酸及沙丁胺醇不缩短ICU患者机械通气时间 | 中国病理生理学会危重病医学专业委员会
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Original Investigation

Caring for the Critically Ill Patient

February 27, 2018

Effect of On-Demand vs Routine Nebulization of Acetylcysteine With Salbutamol on Ventilator-Free Days in Intensive Care Unit Patients Receiving Invasive Ventilation: A Randomized Clinical Trial

David M. P. van Meenen, Sophia M. van der Hoeven, Jan M. Binnekade, et al

JAMA. Published online February 27, 2018. doi:10.1001/jama.2018.0949


Importance 背景

It remains uncertain whether nebulization of mucolytics with bronchodilators should be applied for clinical indication or preventively in intensive care unit (ICU) patients receiving invasive ventilation.


Objective 目的

To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization.


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

Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands.


Interventions 干预措施

On-demand nebulization of acetylcysteine or salbutamol (based on strict clinical indications, n = 471) or routine nebulization of acetylcysteine with salbutamol (every 6 hours until end of invasive ventilation, n = 473).

按需雾化吸入乙酰半胱氨酸或沙丁胺醇(基于严格的临床指证,n = 471)或常规雾化乙酰半胱氨酸及沙丁胺醇(每6小时一次直至有创通气结束,n = 473)。

Main Outcomes and Measures 主要预后指标

The primary outcome was the number of ventilator-free days at day 28, with a noninferiority margin for a difference between groups of −0.5 days. Secondary outcomes included length of stay, mortality rates, occurrence of pulmonary complications, and adverse events.


Results 结果

Nine hundred twenty-two patients (34% women; median age, 66 (interquartile range [IQR], 54-75 years) were enrolled and completed follow-up. At 28 days, patients in the on-demand group had a median 21 (IQR, 0-26) ventilator-free days, and patients in the routine group had a median 20 (IQR, 0-26) ventilator-free days (1-sided 95% CI, −0.00003 to ∞). There was no significant difference in length of stay or mortality, or in the proportion of patients developing pulmonary complications, between the 2 groups. Adverse events (13.8% vs 29.3%; difference, −15.5% [95% CI, −20.7% to −10.3%]; P < .001) were more frequent with routine nebulization and mainly related to tachyarrhythmia (12.5% vs 25.9%; difference, −13.4% [95% CI, −18.4% to −8.4%]; P < .001) and agitation (0.2% vs 4.3%; difference, −4.1% [95% CI, −5.9% to −2.2%]; P < .001).

922名患者(34% 女性;中位年龄,66 岁(四分位区间 [IQR], 54-75 岁))入选并完成随访。在28天时,按需组患者无机械通气天数中位数为21天 (IQR, 0-26),常规治疗组为20天 (IQR, 0-26)(单尾95% CI, −0.00003 to ∞)。两组患者住院日或病死率无显著差异,发生肺部并发症的比例也无显著差异。常规雾化治疗组不良事件发生率更高(13.8% vs 29.3%; 差异,−15.5% [95% CI, −20.7% to −10.3%]; P < .001),主要为快速性心律失常(12.5% vs 25.9%; 差异, −13.4% [95% CI, −18.4% to −8.4%]; P < .001)和躁动(0.2% vs 4.3%;差异,−4.1% [95% CI, −5.9% to −2.2%]; P < .001)。

Conclusions and Relevance 结论与意义

Among ICU patients receiving invasive ventilation who were expected to not be extubated within 24 hours, on-demand compared with routine nebulization of acetylcysteine with salbutamol did not result in an inferior number of ventilator-free days. On-demand nebulization may be a reasonable alternative to routine nebulization.


Trial Registration 试验注册

clinicaltrials.gov Identifier: NCT02159196


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