Boers Noor S, Botta Michela, Tsonas Annisa M, Algera Anna Geke, Pillay Janesh, Dongelmans Dave A, Horn Janneke, Vlaar Alexander P J, Hollmann Markus W, Bos Lieuwe D J, Paulus Frederique, Neto Ary Serpa, Schultz Marcus J
Department of Intensive Care, Amsterdam UMC location AMC, The Netherlands.
Laboratory of Experimental Intensive Care and Anesthesiology (LEICA), Amsterdam UMC location AMC, The Netherlands.
Ann Transl Med. 2020 Oct;8(19):1251. doi: 10.21037/atm-20-5107.
The coronavirus disease 2019 (COVID-19) pandemic is rapidly expanding across the world, with more than 100,000 new cases each day as of end-June 2020. Healthcare workers are struggling to provide the best care for COVID-19 patients. Approaches for invasive ventilation vary widely between and within countries and new insights are acquired rapidly. We aim to investigate invasive ventilation practices and outcome in COVID-19 patients in the Netherlands.
PRoVENT-COVID ('study of PRactice of VENTilation in COVID-19') is an investigator-initiated national, multicenter observational study to be undertaken in intensive care units (ICUs) in The Netherlands. Consecutive COVID-19 patients aged 18 years or older, who are receiving invasive ventilation in the participating ICUs, are to be enrolled during a 10-week period, with a daily follow-up of 7 days. The primary outcome is ventilatory management (including tidal volume expressed as mL/kg predicted body weight and positive end-expiratory pressure expressed as cmHO) during the first 3 days of ventilation. Secondary outcomes include other ventilatory variables, use of rescue therapies for refractory hypoxemia such as prone positioning and extracorporeal membrane oxygenation, use of sedatives, vasopressors and inotropes; daily cumulative fluid balances; acute kidney injury; ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality.
PRoVENT-COVID will be the largest observational study to date, with high density ventilatory data and major outcomes. There is urgent need for a better understanding of ventilation practices, and the effects of ventilator settings on outcomes in COVID-19 patients. The results of PRoVENT-COVID will be rapidly disseminated through electronic presentations, such as webinars and electronic conferences, and publications in international peer-reviewed journals. Access to source data will be made available through local, regional and national anonymized datasets on request, and after agreement of the PRoVENT-COVID steering committee.
PRoVENT-COVID is registered at clinicaltrials.gov (identifier NCT04346342).
2019冠状病毒病（COVID-19）大流行正在全球迅速蔓延，截至2020年6月底，每天新增病例超过10万例。医护人员正在努力为COVID-19患者提供最佳护理。各国之间以及国家内部，有创通气的方法差异很大，并且新的见解迅速涌现。我们旨在调查荷兰COVID-19患者的有创通气实践及结果。
PRoVENT-COVID（“COVID-19通气实践研究”）是一项由研究者发起的全国性多中心观察性研究，将在荷兰的重症监护病房（ICU）中进行。年龄在18岁及以上、正在参与研究的ICU中接受有创通气的连续性COVID-19患者，将在10周内入组，每天进行为期7天的随访。主要结局是通气前3天的通气管理（包括以预测体重的毫升数/千克表示潮气量，以厘米水柱表示呼气末正压）。次要结局包括其他通气变量、用于难治性低氧血症的挽救治疗方法，如俯卧位通气和体外膜肺氧合、镇静剂、血管加压药和正性肌力药的使用；每日累计液体平衡；急性肾损伤；无呼吸机天数和第28天存活情况（VFD-28）、ICU和住院时间，以及ICU、医院和90天死亡率。
PRoVENT-COVID将是迄今为止规模最大的观察性研究，拥有高密度的通气数据和主要结局。迫切需要更好地了解通气实践，以及呼吸机设置对COVID-19患者结局的影响。PRoVENT-COVID的结果将通过网络研讨会和电子会议等电子形式迅速传播，并发表在国际同行评审期刊上。可根据要求，在PRoVENT-COVID指导委员会同意后，通过本地、区域和国家匿名数据集获取源数据。
PRoVENT-COVID已在clinicaltrials.gov注册（标识符NCT04346342）。
