PRactice of VENTilation in Patients with Novel Coronavirus Disease (PRoVENT-COVID)

rationale and protocol for a national multicenter observational study in The Netherlands


<p>Background: 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.</p><p>Methods: 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 cmH2O) 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.</p><p>Discussion: 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.</p><p>Trial Registration: PRoVENT-COVID is registered at (identifier NCT04346342).</p>

Reference Boers, N. S., Botta, M., Tsonas, A. M., Algera, A. G., Pillay, J., Dongelmans, D. A., Horn, J., Vlaar, A. P. J., Hollmann, M. W., Bos, L. D. J., Paulus, F., Neto, A. S., Schultz, M. J., & The PRoVENT-COVID investigators (2020). PRactice of VENTilation in Patients with Novel Coronavirus Disease (PRoVENT-COVID): rationale and protocol for a national multicenter observational study in The Netherlands. Annals of Translational Medicine, 8(19), Article 1251.
Published by  Urban Vitality 1 October 2020

Publication date

Oct 2020


Noor S. Boers
Michela Botta
Annisa M. Tsonas
Anna Geke Algera
Janesh Pillay
Dave A. Dongelmans
Janneke Horn
Alexander P. J. Vlaar
Markus W. Hollmann
Lieuwe D. J. Bos
Frederique Paulus
Ary Serpa Neto
Marcus J. Schultz
The PRoVENT-COVID investigators


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