Effect of On-Demand vs Routine Nebulization of Acetylcysteine With Salbutamol on Ventilator-Free Days in Intensive Care Unit Patients Receiving Invasive Ventilation,JAMA

当前位置： X-MOL 学术 › JAMA › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Effect of On-Demand vs Routine Nebulization of Acetylcysteine With Salbutamol on Ventilator-Free Days in Intensive Care Unit Patients Receiving Invasive Ventilation
JAMA ( IF 63.1 ) Pub Date : 2018-03-13 , DOI: 10.1001/jama.2018.0949
David M. P. van Meenen ₁ , Sophia M. van der Hoeven ₁ , Jan M. Binnekade ₁ , Corianne A. J. M. de Borgie ₂ , Maruschka P. Merkus ₂ , Frank H. Bosch ₃ , Henrik Endeman ₄ , Jasper J. Haringman ₅ , Nardo J. M. van der Meer ₆ , Hazra S. Moeniralam ₇ , Mathilde Slabbekoorn ₈ , Marcella C. A. Muller ₈ , Willemke Stilma ₄ , Bart van Silfhout ₇ , Ary Serpa Neto ₉ , Hans F. M. ter Haar ₅ , Jan Van Vliet ₃ , Jan Willem Wijnhoven ₆ , Janneke Horn _{1,

10} , Nicole P. Juffermans _{1,

10} , Paolo Pelosi ₁₁ , Marcelo Gama de Abreu ₁₂ , Marcus J. Schultz _{1,

10,

13} , Frederique Paulus ₁

Affiliation

Department of Intensive Care, Academic Medical Center, University of Amsterdam, the Netherlands
Clinical Research Unit, Academic Medical Center, University of Amsterdam, the Netherlands
Department of Intensive Care, Rijnstate, Arnhem, the Netherlands
Department of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
Department of Intensive Care, Isala Hospital, Zwolle, the Netherlands
Department of Intensive Care, Amphia Hospital, Breda, the Netherlands
Department of Intensive Care, Antonius Hospital, Nieuwegein, the Netherlands
Department of Intensive Care, Haaglanden Medical Center, The Hague, the Netherlands
Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil
Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, the Netherlands
Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus; Technische Universität Dresden, Dresden, Germany
Mahidol Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand

Importance 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 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 Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands. Interventions 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). Main Outcomes and Measures 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 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). Conclusions and Relevance 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 clinicaltrials.gov Identifier: NCT02159196

中文翻译：

按需与常规雾化乙酰半胱氨酸与沙丁胺醇对接受有创通气的重症监护病房患者无呼吸机天数的影响

重要性对于接受有创通气的重症监护病房 (ICU) 患者，粘液溶解剂与支气管扩张剂的雾化是否应用于临床适应症或预防性治疗仍不确定。目的确定将雾化用于临床适应症（按需）的策略是否不劣于使用预防性（常规）雾化的策略。设计、设置和参与者随机临床试验招募了预计需要在荷兰 7 个 ICU 进行 24 小时以上有创通气的成年患者。干预乙酰半胱氨酸或沙丁胺醇按需雾化（基于严格的临床指征，n = 471）或乙酰半胱氨酸与沙丁胺醇的常规雾化（每 6 小时一次，直至有创通气结束，n = 473）。主要结果和测量主要结果是第 28 天的无呼吸机天数，组间差异为 -0.5 天的非劣效性边际。次要结果包括住院时间、死亡率、肺部并发症的发生率和不良事件。结果 922 名患者（34% 女性；中位年龄 66（四分位距 [IQR]，54-75 岁）被纳入并完成随访。在 28 天时，按需组患者的中位年龄为21 (IQR, 0-26) 无呼吸机天数，常规组患者的中位无呼吸机天数为 20 (IQR, 0-26)（单侧 95% CI，-0.00003 至 ∞）。两组之间的住院时间或死亡率，或发生肺部并发症的患者比例没有显着差异。不良事件（13.8% vs 29.3%；差异，-15. 5% [95% CI，-20.7% 至 -10.3%]；P < .001) 在常规雾化时更频繁，主要与快速性心律失常（12.5% 与 25.9%；差异，-13.4% [95% CI，-18.4% 至 -8.4%]；P < .001）和躁动（ 0.2% 与 4.3%；差异，-4.1% [95% CI，-5.9% 至 -2.2%]；P < .001）。结论和相关性在接受有创通气且预计在 24 小时内不会拔管的 ICU 患者中，与乙酰半胱氨酸和沙丁胺醇的常规雾化相比，按需雾化不会导致无呼吸机天数减少。按需雾化可能是常规雾化的合理替代方案。试验注册clinicaltrials.gov 标识符：NCT02159196 -13.4% [95% CI，-18.4% 至 -8.4%]；P < .001) 和激动（0.2% 与 4.3%；差异，-4.1% [95% CI，-5.9% 至 -2.2%]；P < .001）。结论和相关性在接受有创通气且预计在 24 小时内不会拔管的 ICU 患者中，与乙酰半胱氨酸和沙丁胺醇的常规雾化相比，按需雾化不会导致无呼吸机天数减少。按需雾化可能是常规雾化的合理替代方案。试验注册clinicaltrials.gov 标识符：NCT02159196 -13.4% [95% CI，-18.4% 至 -8.4%]；P < .001) 和激动（0.2% 与 4.3%；差异，-4.1% [95% CI，-5.9% 至 -2.2%]；P < .001）。结论和相关性在接受有创通气且预计在 24 小时内不会拔管的 ICU 患者中，与乙酰半胱氨酸和沙丁胺醇的常规雾化相比，按需雾化不会导致无呼吸机天数减少。按需雾化可能是常规雾化的合理替代方案。试验注册clinicaltrials.gov 标识符：NCT02159196 与乙酰半胱氨酸和沙丁胺醇的常规雾化相比，按需雾化不会导致无呼吸机天数减少。按需雾化可能是常规雾化的合理替代方案。试验注册clinicaltrials.gov 标识符：NCT02159196 与乙酰半胱氨酸和沙丁胺醇的常规雾化相比，按需雾化不会导致无呼吸机天数减少。按需雾化可能是常规雾化的合理替代方案。试验注册clinicaltrials.gov 标识符：NCT02159196

更新日期：2018-03-13

点击分享查看原文

点击收藏

公开下载

阅读更多本刊最新论文