Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy.
Department of Medicine, Anesthesia and Critical Care Unit, Padua University Hospital, Padua, Italy.
PLoS One. 2022 Dec 30;17(12):e0276261. doi: 10.1371/journal.pone.0276261. eCollection 2022.
The worldwide use of prone position (PP) for invasively ventilated patients with COVID-19 is progressively increasing from the first pandemic wave in everyday clinical practice. Among the suggested treatments for the management of ARDS patients, PP was recommended in the Surviving Sepsis Campaign COVID-19 guidelines as an adjuvant therapy for improving ventilation. In patients with severe classical ARDS, some authors reported that early application of prolonged PP sessions significantly decreases 28-day and 90-day mortality.
Since January 2021, the COVID19 Veneto ICU Network research group has developed and implemented nationally and internationally the "PROVENT-C19 Registry", endorsed by the Italian Society of Anesthesia Analgesia Resuscitation and Intensive Care…'(SIAARTI). The PROVENT-C19 Registry wishes to describe 1. The real clinical practice on the use of PP in COVID-19 patients during the pandemic at a National and International level; and 2. Potential baseline and clinical characteristics that identify subpopulations of invasively ventilated patients with COVID-19 that may improve daily from PP therapy. This web-based registry will provide relevant information on how the database research tools may improve our daily clinical practice.
This multicenter, prospective registry is the first to identify and characterize the role of PP on clinical outcome in COVID-19 patients. In recent years, data emerging from large registries have been increasingly used to provide real-world evidence on the effectiveness, quality, and safety of a clinical intervention. Indeed observation-based registries could be effective tools aimed at identifying specific clusters of patients within a large study population with widely heterogeneous clinical characteristics.
The registry was registered (ClinicalTrial.Gov Trials Register NCT04905875) on May 28,2021.
在 COVID-19 大流行期间，从第一波疫情开始，全球范围内对接受有创通气的俯卧位（PP）患者的使用逐渐增加。在管理 ARDS 患者的建议治疗方法中，俯卧位通气作为一种辅助治疗方法被推荐用于改善通气，这在《拯救脓毒症运动 COVID-19 指南》中有所提及。对于严重的经典 ARDS 患者，一些作者报告称，早期应用长时间的俯卧位通气显著降低了 28 天和 90 天的死亡率。
自 2021 年 1 月以来，COVID19 威尼托 ICU 网络研究小组已在国家和国际层面上制定和实施了“PROVENT-C19 登记”，并得到了意大利麻醉、镇痛、复苏和重症监护学会（SIAARTI）的认可。PROVENT-C19 登记希望描述 1. 在大流行期间，COVID-19 患者中俯卧位通气的实际临床应用在全国和国际层面上的情况；2. 确定可能从俯卧位治疗中获益的 COVID-19 患者亚群的潜在基线和临床特征。这个基于网络的登记将提供有关数据库研究工具如何提高我们日常临床实践的相关信息。
这项多中心、前瞻性登记研究首次确定并描述了俯卧位对 COVID-19 患者临床结局的作用。近年来，越来越多的大型登记研究数据被用于提供临床干预措施有效性、质量和安全性的真实世界证据。事实上，观察性登记研究可能是一种有效的工具，旨在确定具有广泛异质性临床特征的大型研究人群中特定的患者群体。
该登记于 2021 年 5 月 28 日在 ClinicalTrial.Gov Trials Register（NCT04905875）注册。
