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

Study Overview
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Brief Summary
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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
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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.

Official Title
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PRactice of VENTilation in COVID-19 Patients (PRoVENT-COVID) - an Observational Study of Invasively Ventilated Patients in the Netherlands

Conditions
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COVID, Mechanical Ventilation, Acute Respiratory Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical ventilation<br>COVID patients receiving invasive mechanical ventilation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilation-free days and alive at day 28 |  | Until 28 days from initiation of mechanical ventilation | 
| Duration of ventilation in survivors; | time between start invasive ventilation and successful extubation 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 | 
| Duration of ICU stay | Time between admission and discharge ICU or death in ICU | Until 28 days from initiation of mechanical ventilation | 
| Duration of hospital stay | Time between admission and discharge from hospital or death in hospital | Until 28 days from initiation of mechanical ventilation | 
| ICU mortality | Any death during ICU stay | Until 28 days from initiation of mechanical ventilation | 
| Hospital mortality | Any death during hospital stay | Until 28 days from initiation of mechanical ventilation | 
| 28-day mortality |  | Until 28 days from initiation of mechanical ventilation | 
| 90-day mortality |  | Until 90 days from initiation of mechanical ventilation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID