NCT04346342|Completed
PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)
PRoVENT-COVID
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PRoVENT-COVID
Sponsor study identifier
observational
1,122
1 country
22
Study Start
March 6, 2020
Actual (reported)Primary Completion
September 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)The purpose of this national, multicenter service review is to determine and compare ventilation management in COVID-19 patients in the Netherlands, and to determine whether certain ventilation settings have an independent association with duration of ventilation. In every adult invasively ventilated COVID-19 patient from a participating ICU, granular ventilator settings and parameters will be collected from start of invasive ventilation for up to 72 hours. Follow up is until ICU and hospital discharge, and until day 90. The primary outcome includes main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate). Secondary endpoints are ventilator-free days and alive at day 28 (VFD-28); duration of mechanical ventilation; use of prone positioning and recruitment maneuvers; duration of ICU and hospital stay; incidence of kidney injury; and ICU, hospital, 28-day and 90-day mortality.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2020
Actual (reported)April 9, 2020
Actual (reported)April 15, 2020
Actual (reported)September 1, 2020
Actual (reported)September 1, 2020
Actual (reported)Ventilation Mode
Day 1 to Day 3 from initiation of mechanical ventilation
Tidal volume set
Day 1 to Day 3 from initiation of mechanical ventilation
Expiratory tidal volume
Day 1 to Day 3 from initiation of mechanical ventilation
Positive end-expiratory pressure
Day 1 to Day 3 from initiation of mechanical ventilation
Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);
Day 1 to Day 3 from initiation of mechanical ventilation
Number of ventilation-free days and alive at day 28
Until 28 days from initiation of mechanical ventilation
Duration of ventilation in survivors;
Until 28 days from initiation of mechanical ventilation
Use of prone positioning
Day 1 to Day 3 from initiation of mechanical ventilation
Use of recruitment maneuvers
Day 1 to Day 3 from initiation of mechanical ventilation
Incidence of acute kidney injury
Until 28 days from initiation of mechanical ventilation
COVID patients receiving invasive mechanical ventilation
Invasively ventilated patients with COVID-19.
Flevoziekenhuis
Almere Stad, Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Gelre ziekenhuizen
Apeldoorn, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Ahuja S, de Grooth HJ, Paulus F, van der Ven FL, Serpa Neto A, Schultz MJ, Tuinman PR; PRoVENT-COVID Study Collaborative Group* 'PRactice of VENTilation in COVID-19'. Association between early cumulative fluid balance and successful liberation from invasive ventilation in COVID-19 ARDS patients - insights from the PRoVENT-COVID study: a national, multicenter, observational cohort analysis. Crit Care. 2022 Jun 1;26(1):157. doi: 10.1186/s13054-022-04023-y.
Schuijt MTU, van Meenen DMP, Martin-Loeches I, Mazzinari G, Schultz MJ, Paulus F, Serpa Neto A. Association of Time-Varying Intensity of Ventilation With Mortality in Patients With COVID-19 ARDS: Secondary Analysis of the PRoVENT-COVID Study. Front Med (Lausanne). 2021 Nov 18;8:725265. doi: 10.3389/fmed.2021.725265. eCollection 2021.
Marcus Schultz, MD, PhD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Frederique Paulus, PhD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Ary Serpa Neto, MD, PhD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Anna Geke Algera, MD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
1,122 participants (actual enrollment reported by the registry).
First Submitted
April 9, 2020
First Posted
April 15, 2020
Study Start
March 6, 2020
Actual (reported)Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients
Level of pressure support above positive end-expiratory pressure (PEEP)
Day 1 to Day 3 from initiation of mechanical ventilation
Inspired fraction of oxygen
Day 1 to Day 3 from initiation of mechanical ventilation
Set and measured respiratory rate
Day 1 to Day 3 from initiation of mechanical ventilation
Inspiration to expiration ratio
Day 1 to Day 3 from initiation of mechanical ventilation
Contact the study team to confirm eligibility.
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Maxima Medical Center
Eindhoven, Netherlands
St Anna Ziekenhuis
Geldrop, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Dijklander Ziekenhuis
Hoorn, Netherlands
Leeuwarden Medisch Centrum
Leeuwarden, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Zuyderland Medisch Centrum
Sittard, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Isala Ziekenhuis
Zwolle, Netherlands
Bos LDJ, Sjoding M, Sinha P, Bhavani SV, Lyons PG, Bewley AF, Botta M, Tsonas AM, Serpa Neto A, Schultz MJ, Dickson RP, Paulus F; PRoVENT-COVID collaborative group. Longitudinal respiratory subphenotypes in patients with COVID-19-related acute respiratory distress syndrome: results from three observational cohorts. Lancet Respir Med. 2021 Dec;9(12):1377-1386. doi: 10.1016/S2213-2600(21)00365-9. Epub 2021 Oct 13.
Schuijt MTU, Schultz MJ, Paulus F, Serpa Neto A; PRoVENT-COVID Collaborative Group. Association of intensity of ventilation with 28-day mortality in COVID-19 patients with acute respiratory failure: insights from the PRoVENT-COVID study. Crit Care. 2021 Aug 6;25(1):283. doi: 10.1186/s13054-021-03710-6.
Valk CMA, Tsonas AM, Botta M, Bos LDJ, Pillay J, Serpa Neto A, Schultz MJ, Paulus F; Writing Committee for the PRoVENT-COVID * Collaborative Group. Association of early positive end-expiratory pressure settings with ventilator-free days in patients with coronavirus disease 2019 acute respiratory distress syndrome: A secondary analysis of the Practice of VENTilation in COVID-19 study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1274-1283. doi: 10.1097/EJA.0000000000001565.
Boers NS, Botta M, Tsonas AM, Algera AG, Pillay J, Dongelmans DA, Horn J, Vlaar APJ, Hollmann MW, Bos LDJ, Paulus F, Neto AS, Schultz MJ; PRoVENT-COVID investigatorsdagger. PRactice of VENTilation in Patients with Novel Coronavirus Disease (PRoVENT-COVID): rationale and protocol for a national multicenter observational study in The Netherlands. Ann Transl Med. 2020 Oct;8(19):1251. doi: 10.21037/atm-20-5107.
Botta M, Tsonas AM, Pillay J, Boers LS, Algera AG, Bos LDJ, Dongelmans DA, Hollmann MW, Horn J, Vlaar APJ, Schultz MJ, Neto AS, Paulus F; PRoVENT-COVID Collaborative Group. Ventilation management and clinical outcomes in invasively ventilated patients with COVID-19 (PRoVENT-COVID): a national, multicentre, observational cohort study. Lancet Respir Med. 2021 Feb;9(2):139-148. doi: 10.1016/S2213-2600(20)30459-8. Epub 2020 Oct 23.
Anissa Tsonas, MD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Michela Botta, MD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Primary Completion
September 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)Last Updated
July 6, 2021
Record last verified: 2021-07
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