PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID)
- Conditions
- Mechanical VentilationCOVIDAcute Respiratory Failure
- Registration Number
- NCT04346342
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1122
- 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
- Age <18 years
- Already included in the same study in another hospital
- Having had received invasive ventilation > 24 hours in a non-participating hospital
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Ventilation Mode 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 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 Inspiration to expiration ratio Day 1 to Day 3 from initiation of mechanical ventilation
- Secondary Outcome Measures
Name Time Method 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 Duration of hospital stay Until 28 days from initiation of mechanical ventilation Time between admission and discharge from hospital or death in hospital
ICU mortality Until 28 days from initiation of mechanical ventilation Any death during ICU stay
Duration of ventilation in survivors; Until 28 days from initiation of mechanical ventilation time between start invasive ventilation and successful extubation in survivors
Use of prone positioning Day 1 to Day 3 from initiation of mechanical ventilation Hospital mortality Until 28 days from initiation of mechanical ventilation Any death during hospital stay
28-day mortality Until 28 days from initiation of mechanical ventilation Number of ventilation-free days and alive at day 28 Until 28 days from initiation of mechanical ventilation 90-day mortality Until 90 days from initiation of mechanical ventilation Duration of ICU stay Until 28 days from initiation of mechanical ventilation Time between admission and discharge ICU or death in ICU
Trial Locations
- Locations (22)
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Reinier de Graaf Gasthuis
🇳🇱Delft, Netherlands
Maxima Medical Center
🇳🇱Eindhoven, Netherlands
Dijklander Ziekenhuis
🇳🇱Hoorn, Netherlands
Isala Ziekenhuis
🇳🇱Zwolle, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Zuyderland Medisch Centrum
🇳🇱Sittard, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
Haaglanden Medisch Centrum
🇳🇱Den Haag, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Rijnstate Ziekenhuis
🇳🇱Arnhem, Netherlands
Ziekenhuis Gelderse Vallei
🇳🇱Ede, Netherlands
Leeuwarden Medisch Centrum
🇳🇱Leeuwarden, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
🇳🇱Amsterdam, Netherlands
Gelre ziekenhuizen
🇳🇱Apeldoorn, Netherlands
HagaZiekenhuis
🇳🇱Den Haag, Netherlands
St Anna Ziekenhuis
🇳🇱Geldrop, Netherlands