Simonis Fabienne D, Binnekade Jan M, Braber Annemarije, Gelissen Harry P, Heidt Jeroen, Horn Janneke, Innemee Gerard, de Jonge Evert, Juffermans Nicole P, Spronk Peter E, Steuten Lotte M, Tuinman Pieter Roel, Vriends Marijn, de Vreede Gwendolyn, de Wilde Rob B, Serpa Neto Ary, Gama de Abreu Marcelo, Pelosi Paolo, Schultz Marcus J
Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.
Department of Intensive Care, Gelre Hospitals, Apeldoorn, The Netherlands.
Trials. 2015 May 24;16:226. doi: 10.1186/s13063-015-0759-1.
It is uncertain whether lung-protective mechanical ventilation using low tidal volumes should be used in all critically ill patients, irrespective of the presence of the acute respiratory distress syndrome (ARDS). A low tidal volume strategy includes use of higher respiratory rates, which could be associated with increased sedation needs, a higher incidence of delirium, and an increased risk of patient-ventilator asynchrony and ICU-acquired weakness. Another alleged side-effect of low tidal volume ventilation is the risk of atelectasis. All of these could offset the beneficial effects of low tidal volume ventilation as found in patients with ARDS.
METHODS/DESIGN: PReVENT is a national multicenter randomized controlled trial in invasively ventilated ICU patients without ARDS with an anticipated duration of ventilation of longer than 24 hours in 5 ICUs in The Netherlands. Consecutive patients are randomly assigned to a low tidal volume strategy using tidal volumes from 4 to 6 ml/kg predicted body weight (PBW) or a high tidal volume ventilation strategy using tidal volumes from 8 to 10 ml/kg PBW. The primary endpoint is the number of ventilator-free days and alive at day 28. Secondary endpoints include ICU and hospital length of stay (LOS), ICU and hospital mortality, the incidence of pulmonary complications, including ARDS, pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives and neuromuscular blocking agents, incidence of ICU delirium, and the need for decreasing of instrumental dead space.
PReVENT is the first randomized controlled trial comparing a low tidal volume strategy with a high tidal volume strategy, in patients without ARDS at onset of ventilation, that recruits a sufficient number of patients to test the hypothesis that a low tidal volume strategy benefits patients without ARDS with regard to a clinically relevant endpoint.
The trial is registered at www.clinicaltrials.gov under reference number NCT02153294 on 23 May 2014.
对于所有重症患者，无论是否存在急性呼吸窘迫综合征（ARDS），是否均应采用低潮气量的肺保护性机械通气尚不确定。低潮气量策略包括使用较高的呼吸频率，这可能会导致镇静需求增加、谵妄发生率升高、患者-呼吸机不同步及ICU获得性肌无力风险增加。低潮气量通气的另一个所谓副作用是肺不张风险。所有这些都可能抵消在ARDS患者中发现的低潮气量通气的有益效果。
方法/设计：PReVENT是一项荷兰5家ICU针对无ARDS且预期机械通气时间超过24小时的有创通气ICU患者开展的全国多中心随机对照试验。连续入选的患者被随机分配至低潮气量策略组，采用4至6 ml/kg预计体重（PBW）的潮气量，或高潮气量通气策略组，采用8至10 ml/kg PBW的潮气量。主要终点是第28天时无呼吸机天数且存活。次要终点包括ICU和医院住院时间（LOS）、ICU和医院死亡率、肺部并发症发生率，包括ARDS、肺炎、肺不张和气胸、镇静剂和神经肌肉阻滞剂的累积使用量及持续时间、ICU谵妄发生率，以及减少器械死腔的必要性。
PReVENT是第一项在通气开始时无ARDS的患者中比较低潮气量策略与高潮气量策略的随机对照试验，该试验纳入了足够数量的患者以检验以下假设：就临床相关终点而言，低潮气量策略对无ARDS的患者有益。
该试验于2014年5月23日在www.clinicaltrials.gov注册，注册号为NCT02153294。
