PRactice of VENTilation in Patients With ARDS Due to COVID-19 vs Pneumonia

Study Overview
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Brief Summary
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This study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection. The investigators will use individual patient data from four recently published large observational COVID-9 studies, including the 'Practice of VENTilation in COVID-19 patients' (PRoVENT-COVID) study, the 'Epidemiology of COVID-19 patients in the ICU' (EPICCoV) study, the 'SATI-COVID-19 - Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study' and the CIBERESUCICOVID - Personalized Risk and Prognosis Factors and Follow-up at One Year of the Patients Hospitalized in the Spanish Intensive Care Units Infected with COVID -19' study. The investigators will use the individual patient data from ARDS patients with another pulmonary infection from the 'LUNG -SAFE - Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE' study and the 'ERICC - Epidemiology of Respiratory Insufficiency in Critical Care' study.

Detailed Description
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Early on in the pandemic, it was frequently proposed that ARDS caused by COVID-19 and ARDS caused by another cause were distinct in a number of ways. COVID-19 related ARDS phenotypes have been suggested, based on differences in respiratory system compliance (Crs) and the severity of the hypoxemia. Other reports have even suggested that lung-protective ventilation strategies for patients with ARDS caused by COVID-19 should differ from those used before the pandemic. The use of low tidal volumes (VT) and prone positioning, which have been shown to be useful in reducing death in patients with ARDS prior to the pandemic, were also shown to be effective in patients with COVID-19 related ARDS, according to several reports. In the discussion of how to ventilate patients with COVID-19 related ARDS, the disagreement over other ventilatory settings, such as the best positive end-expiratory pressure (PEEP) and the use of recruitment manoeuvres, remains remarkably lively. To compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with COVID-19 ARDS and ARDS from another pulmonary infection, the investigators will use individual patient data from PRoVENT-COVID, EPICCoV, SATI-COVID-19, CIBERESUCICOVID, LUNG-SAFE and ERICC.

Official Title
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PRactice of VENTilation in Patients With ARDS Due to COVID-19 Versus ARDS Due to Other Pulmonary Infections (PRoVENT-COP)

Conditions
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Acute Respiratory Distress Syndrome, COVID-19, Pneumonia, Mechanical Ventilation Complication

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cause for ARDS is COVID -19 (confirmed with polymerase chain reaction (PCR) and/or presence of typical abnormalities on chest computer tomography (CT) and/or X-ray) or a pulmonary infection from another origen Meeting a Berlin criteria for ARDS Invasive ventilation Exclusion Criteria: Age < 18 years Any form of non-invasive ventilation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Non-COVID-19 ARDS<br>To be included in this analysis the cause for ARDS was a pulmonary infection other than COVID-19 and meeting all aspects of the Berlin definition. | |
| COVID-19 ARDS<br>To be included in this analysis the cause for ARDS was COVID-19 and meeting all aspects of the Berlin definition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of invasive ventilation | A combination of key ventilation characteristics, including tidal volume (VT); positive end-expiratory pressure (PEEP); fraction inspired oxygen (FiO2); peak pressure (Ppeak) and plateau pressure (Pplat); respiratory rate (RR); driving pressure (ΔP); respiratory system compliance (CRS) and mechanical power of ventilation (MP). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days | Liberated of invasive ventilation and alive | 28 days | 
| Incidence of ICU mortality | Incidence of ICU mortality at day 28 and at day 90 | 90 days | 
| Incidence of in-hospital mortality | Incidence of in-hospital mortality at day 28 and at day 90 | 90 days | 
| ICU length of stay | ICU length of stay at day 28 and at day 90 | 90 days | 
| Hospital length of stay | Hospital length of stay at day 28 and at day 90 | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Acute Respiratory Distress Syndrome, Ventilation practice, Pulmonary infection, COVID-19