Clinical trial NCT04346342: PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)
Official title: PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Mechanical Ventilation
Acute Respiratory Failure
Keywords: COVID
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 1122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Invasively ventilated patients with COVID-19.

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.

Detailed description: Rationale:

The novel coronavirus disease (COVID-19) pandemic is rapidly expanding across the world, with over 60.000 new cases each day as of late March 2020. Healthcare workers are struggling to provide the best care for patients with proven or suspected COVID-19. Approaches for clinical care vary widely between and within countries and new insights are acquired rapidly. This includes the way invasive ventilation is applied.

Objective:

To determine and compare invasive ventilation settings and parameters in COVID-19 patients in the Netherlands, and to determine associations with clinical outcomes.

Hypotheses:

Invasive ventilation settings and parameters vary between intensive care units (ICUs) in hospitals in the Netherlands; certain ventilator settings have an independent association with duration of ventilation in COVID-19 patients.

Study design:

Multicenter, national, retrospective, observational study in COVID-19 patients with respiratory failure, requiring invasive ventilation in intensive care unit (ICU) in hospitals in the Netherlands.

Study population:

The data of at least 1,000 consecutively invasively ventilated COVID-19 patients admitted to intensive care units (ICUs) of hospitals in the Netherlands. This study will not be restricted to the 'formal' ICUs, as patients may also receive invasive ventilation in other locations within the hospital during the COVID-19 pandemic.

Methods:

In every patient, granular ventilator settings and parameters are collected from start of invasive ventilation for up to 72 hours. Patients will be followed up until ICU and hospital discharge, and until day 90.

Sample size calculation:

No formal sample size calculation is needed. We expect to capture at least 1,000 patients, but will continue collecting data of new patients for at least 8 weeks.

Study endpoints:

Main ventilator settings (including tidal volume, airway pressures, oxygen fraction and respiratory rate) (primary) and parameters (blood gas results); use of rescue therapies (including prone positioning); use of sedatives, vasopressors and inotropes; daily cumulative fluid balances; development of 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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Retrospective collection of data regarding ventilation management and major clinical endpoints is without risk for the individual patient.

Eligibility criteria: Inclusion Criteria:

* COVID-19, confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT)
* Suspected COVID-19 infection, with no exclusion of diagnosis
* Having received invasive ventilation

Exclusion Criteria:

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

Primary outcomes:
measure: Ventilation Mode
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Tidal volume set
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Expiratory tidal volume
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Positive end-expiratory pressure
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Maximum airway pressure or plateau pressure (P plateau) or peak pressure (P peak) (cm H2O);
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Level of pressure support above positive end-expiratory pressure (PEEP)
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Inspired fraction of oxygen
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Set and measured respiratory rate
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Inspiration to expiration ratio
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
Secondary outcomes:
measure: Number of ventilation-free days and alive at day 28
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: Duration of ventilation in survivors;
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: Use of prone positioning
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Use of recruitment maneuvers
timeFrame: Day 1 to Day 3 from initiation of mechanical ventilation
measure: Incidence of acute kidney injury
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: Duration of ICU stay
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: Duration of hospital stay
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: ICU mortality
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: Hospital mortality
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: 28-day mortality
timeFrame: Until 28 days from initiation of mechanical ventilation
measure: 90-day mortality
timeFrame: Until 90 days from initiation of mechanical ventilation
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Apeldoorn
country: Netherlands
facility: Gelre ziekenhuizen
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Maxima Medical Center
city: Geldrop
country: Netherlands
facility: St Anna Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Leeuwarden Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Sittard
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala Ziekenhuis
Study officials:
affiliation: Department of Intensive Care, Academic Medical Center, University of Amsterdam
name: Marcus Schultz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Intensive Care, Academic Medical Center, University of Amsterdam
name: Frederique Paulus, PhD
role: STUDY_CHAIR
affiliation: Department of Intensive Care, Academic Medical Center, University of Amsterdam
name: Ary Serpa Neto, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Intensive Care, Academic Medical Center, University of Amsterdam
name: Anna Geke Algera, MD
role: STUDY_DIRECTOR
affiliation: Department of Intensive Care, Academic Medical Center, University of Amsterdam
name: Anissa Tsonas, MD
role: STUDY_DIRECTOR
affiliation: Department of Intensive Care, Academic Medical Center, University of Amsterdam
name: Michela Botta, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.