PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)

NCT04346342 | Completed

• 1 other identifier: PRoVENT-COVID
• Study Type: observational
• Target: 1,122
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

COVID; Mechanical Ventilation; Acute Respiratory Failure

Keywords

COVID

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Secondary Outcomes (11)

• 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

Study Arms (1)

Mechanical ventilation

COVID patients receiving invasive mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invasively ventilated patients with COVID-19.

You may qualify if:

• COVID-19, confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT)
• Having received invasive ventilation

You may not qualify if:

• Age \<18 years
• Already included in the same study in another hospital
• Having had received invasive ventilation \> 24 hours in a non-participating hospital

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (22)

Flevoziekenhuis

Almere Stad, Netherlands

Location

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Gelre ziekenhuizen

Apeldoorn, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Maxima Medical Center

Eindhoven, Netherlands

Location

St Anna Ziekenhuis

Geldrop, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Location

Spaarne Gasthuis

Haarlem, Netherlands

Location

Dijklander Ziekenhuis

Hoorn, Netherlands

Location

Leeuwarden Medisch Centrum

Leeuwarden, Netherlands

Location

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

Zuyderland Medisch Centrum

Sittard, Netherlands

Location

Haaglanden Medisch Centrum

The Hague, Netherlands

Location

HagaZiekenhuis

The Hague, Netherlands

Location

Isala Ziekenhuis

Zwolle, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 35650616 DERIVED

• 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.

  PMID: 34869421 DERIVED

• 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.

  PMID: 34653374 DERIVED

• 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.

  PMID: 34362415 DERIVED

• 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.

  PMID: 34238782 DERIVED

• 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.

  PMID: 33178783 DERIVED

• 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.

  PMID: 33169671 DERIVED

Study Officials

• Marcus Schultz, MD, PhD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Frederique Paulus, PhD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY CHAIR

• Ary Serpa Neto, MD, PhD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY CHAIR

• Anna Geke Algera, MD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY DIRECTOR

• Anissa Tsonas, MD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY DIRECTOR

• Michela Botta, MD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 15, 2020
• Study Start: March 6, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 6, 2021

Record last verified: 2021-07

Locations

NL (22)