Effect of Not Monitoring Residual Gastric Volume on Risk of Ventilator-Associated Pneumonia in Adults Receiving Mechanical Ventilation and Early Enteral Feeding A Randomized Controlled Trial

Effect of Not Monitoring Residual Gastric Volume on Risk of Ventilator-Associated Pneumonia in Adults Receiving Mechanical Ventilation and Early Enteral Feeding A Randomized Controlled Trial
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DOI:
10.1001/jama.2012.196377
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发表时间:
2013-01-16
影响因子:
120.7
通讯作者:
Lascarrou, Jean-Baptiste
Lascarrou, Jean-Baptiste
中科院分区:
医学1区
文献类型:
--
作者:
Reignier, Jean;Mercier, Emmanuelle;Lascarrou, Jean-Baptiste

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对早期肠内营养患者进行残胃量监测是预防呼吸机相关性肺炎(VAP)的重要措施。然而,研究对这一措施的可靠性和有效性提出了挑战。目的在接受有创机械通气和早期肠内营养的患者中,与常规残余胃容量监测相比,当不监测残余胃容量时,VAP的风险不会增加。设计,设置和患者随机,非劣效性,开放标签,2010年5月至2011年3月在9个法国重症监护室(ICU)进行的一项多中心试验,在需要有创机械通气超过2天并在插管后36小时内给予肠内营养的成人中进行; 452名患者被随机分组,449名患者被纳入意向治疗分析(3名患者撤回了最初的同意)。肠内营养不耐受仅基于反流和呕吐的干预组和基于残余胃容量大于250毫升,在任何6小时测量和反流或呕吐的对照group.Main结果测量至少1 VAP发作后90天内随机分组的患者比例,由一个不知情的患者组的裁定委员会评估。结果在意向治疗人群中,干预组227例患者中有38例(16.7%)发生VAP,对照组222例患者中有35例(15.8%)发生VAP,差异为0.9%,90%CI为-4.8%~6.7%。在其他ICU获得性感染、机械通气持续时间、ICU住院时间或死亡率方面,组间无显著差异。干预组中接受100%热量目标的患者比例较高(比值比,1.77; 90%CI,1.25-2.51; P =. 008)。在符合协议population.Conclusion和相关性成人需要机械通气和接受早期肠内营养,胃容量监测的情况下,并不低于常规残留胃容量监测VAP的发展。
Importance Monitoring of residual gastric volume is recommended to prevent ventilator-associated pneumonia (VAP) in patients receiving early enteral nutrition. However, studies have challenged the reliability and effectiveness of this measure.Objective To test the hypothesis that the risk of VAP is not increased when residual gastric volume is not monitored compared with routine residual gastric volume monitoring in patients receiving invasive mechanical ventilation and early enteral nutrition.Design, Setting, and Patients Randomized, noninferiority, open-label, multi-center trial conducted from May 2010 through March 2011 in adults requiring invasive mechanical ventilation for more than 2 days and given enteral nutrition within 36 hours after intubation at 9 French intensive care units (ICUs); 452 patients were randomized and 449 included in the intention-to-treat analysis (3 withdrew initial consent).Intervention Absence of residual gastric volume monitoring. Intolerance to enteral nutrition was based only on regurgitation and vomiting in the intervention group and based on residual gastric volume greater than 250 mL at any of the 6 hourly measurements and regurgitation or vomiting in the control group.Main Outcome Measures Proportion of patients with at least 1 VAP episode within 90 days after randomization, as assessed by an adjudication committee blinded to patient group. The prestated noninferiority margin was 10%.Results In the intention-to-treat population, VAP occurred in 38 of 227 patients (16.7%) in the intervention group and in 35 of 222 patients (15.8%) in the control group (difference, 0.9%; 90% CI, -4.8% to 6.7%). There were no significant between-group differences in other ICU-acquired infections, mechanical ventilation duration, ICU stay length, or mortality rates. The proportion of patients receiving 100% of their calorie goal was higher in the intervention group (odds ratio, 1.77; 90% CI, 1.25-2.51; P =. 008). Similar results were obtained in the per-protocol population.Conclusion and Relevance Among adults requiring mechanical ventilation and receiving early enteral nutrition, the absence of gastric volume monitoring was not inferior to routine residual gastric volume monitoring in terms of development of VAP.