The PROVENT-C19 registry: A study protocol for international multicenter SIAARTI registry on the use of prone positioning in mechanically ventilated patients with COVID-19 ARDS

• Published in: PloS one Vol. 17; no. 12; p. e0276261
• Main Authors: De Rosa, Silvia, Sella, Nicolò, Rezoagli, Emanuele, Lorenzoni, Giulia, Gregori, Dario, Bellani, Giacomo, Foti, Giuseppe, Pettenuzzo, Tommaso, Baratto, Fabio, Fullin, Giorgio, Papaccio, Francesco, Peta, Mario, Poole, Daniele, Toffoletto, Fabio, Maggiore, Salvatore Maurizio, Navalesi, Paolo
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 30.12.2022; Public Library of Science (PLoS)
• Subjects: Analgesia; Anesthesia; Artificial respiration; Biology and Life Sciences; Clinical medicine; Clinical trials; Complications and side effects; Confidence intervals; Coronaviruses; COVID-19; COVID-19 - therapy; Endorsements; Enrollments; Humans; Infections; Intensive care; Lung; Mechanics; Medical research; Medicine and Health Sciences; Mortality; Multicenter Studies as Topic; Pain perception; Pandemics; Patient outcomes; Patient positioning; Personal information; Physical Sciences; Pneumonia; Population studies; Prone Position; Respiration, Artificial - methods; Respiratory Distress Syndrome - therapy; Sepsis; Severe acute respiratory syndrome coronavirus 2; Study Protocol; Subpopulations; Ventilation; Ventilators; Italy; Egypt
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0276261

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.